Medical Device Manufacturer · US , Mchenry , IL

Syva Co.

448 submissions · 447 cleared · Since 1976
448
Total
447
Cleared
0
Denied

Syva Co. — FDA 510(k) Submissions

Syva Co. has submitted 448 FDA 510(k) premarket notifications since 1976, of which 447 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Drug Specific Control Materials, Calibrators, Drug Mixture, Calibrators, Drug Specific, Enzyme Immunoassay, Cannabinoids, Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine . Use the specialty filter in the sidebar to narrow results.

448 devices
1–25 of 448
EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL
K011878 · DKJ Colorimetry, Salicylate · Toxicology
Aug 2001 59d
EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
K012257 · DKZ Enzyme Immunoassay,... · Chemistry
Aug 2001 16d
EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
K011947 · LEG Enzyme Immunoassay,... · Toxicology
Jul 2001 11d
EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
K011528 · DLZ Enzyme Immunoassay,... · Chemistry
Jun 2001 20d
EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
K011347 · DIP Enzyme Immunoassay,... · Toxicology
May 2001 15d
SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL
K993980 · DML Nad-nadh, Specific... · Toxicology
Feb 2000 69d
SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL
K993981 · JXN Enzyme Immunoassay,... · Toxicology
Feb 2000 69d
ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS
K993026 · DIP Enzyme Immunoassay,... · Toxicology
Jan 2000 140d
ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90
K993028 · KLT Enzyme Immunoassay,... · Toxicology
Jan 2000 140d
ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89
K993029 · KLS Enzyme Immunoassay,... · Toxicology
Jan 2000 140d
ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54
K993031 · DLZ Enzyme Immunoassay,... · Toxicology
Jan 2000 140d
SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL
K993982 · LAF Gas Chromatography,... · Toxicology
Jan 2000 64d
SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL
K993983 · LCM Enzyme Immunoassay,... · Toxicology
Jan 2000 64d
SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL
K993985 · JXM Enzyme Immunoassay,... · Toxicology
Jan 2000 64d
SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL
K993986 · KXS Radioimmunoassay,... · Toxicology
Jan 2000 64d
SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL
K993987 · KLT Enzyme Immunoassay,... · Toxicology
Jan 2000 64d
SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL
K993988 · DIO Enzyme Immunoassay,... · Toxicology
Jan 2000 64d
SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL
K994005 · DJR Enzyme Immunoassay,... · Chemistry
Jan 2000 57d
SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL
K993984 · LDJ Enzyme Immunoassay,... · Toxicology
Jan 2000 55d
EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5
K993755 · DKB Calibrators, Drug Mixture · Toxicology
Dec 1999 46d
MODIFICATION OF EMIT D.A.U. OPIATES ASSAY
K984232 · DJG Enzyme Immunoassay, Opiates · Toxicology
Jan 1999 58d
EMIT 2000 DIGOXIN ASSAY
K951755 · KXT Enzyme Immunoassay, Digoxin · Chemistry
Jun 1995 45d
EMIT IIC CALIBRATORS
K935192 · DKB Calibrators, Drug Mixture · Chemistry
Mar 1995 514d
EMIT IIC BARBITURATE ASSAY
K935116 · DIS Enzyme Immunoassay,... · Toxicology
Feb 1995 483d
EMIT IIC PHENCYCLIDINE ASSAY
K935191 · LCM Enzyme Immunoassay,... · Toxicology
Feb 1995 484d

Looking for a specific device from Syva Co.? Search by device name or K-number.

Search all Syva Co. devices
Filters