Medical Device Manufacturer · US , Mchenry , IL

Miles Laboratories, Inc.

158 submissions · 158 cleared · Since 1976
158
Total
158
Cleared
0
Denied

Miles Laboratories, Inc. — FDA 510(k) Submissions

Miles Laboratories, Inc. has submitted 158 FDA 510(k) premarket notifications since 1976, of which 158 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Glucose Oxidase, Glucose, Calculator/data Processing Module, For Clinical Use, Automated Urinalysis System, Radioimmunoassay, Total Thyroxine, Processor, Tissue, Automated . Use the specialty filter in the sidebar to narrow results.

158 devices
1–25 of 158
LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER
K880605 · FPB Filter, Infusion Line · General Hospital
May 1988 104d
MICRO-BUMINTEST REAGENT TABLETS
K874909 · JIR Indicator Method, Protein... · Chemistry
Apr 1988 149d
MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE
K875079 · CKA Nadh Oxidation/nad... · Chemistry
Apr 1988 118d
GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT
K871835 · CGA Glucose Oxidase, Glucose · Chemistry
Dec 1987 225d
SERALYZER III BLOOD CHEMISTRY ANALYZER
K872120 · JJF Analyzer, Chemistry,... · Chemistry
Oct 1987 149d
CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)
K873304 · LJX Test, Urine Leukocyte · Hematology
Sep 1987 24d
CUTTER PUREFLO PLUS IV FILTER
K872634 · FPB Filter, Infusion Line · General Hospital
Aug 1987 29d
MODIFIED SALTEX REAGENT STRIPS
K870214 · CHK Mercuric Nitrate And... · Chemistry
Jun 1987 160d
SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS
K870752 · CFJ Nad Reduction/nadh... · Chemistry
Apr 1987 48d
SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI.
K864530 · CGA Glucose Oxidase, Glucose · Chemistry
Feb 1987 93d
SERA-TEK MICROSOMAL ANTIBODY TEST
K865053 · JZO System, Test, Thyroid... · Chemistry
Feb 1987 56d
SERA-TEK THYROGLOBULIN ANTIBODY TEST
K865020 · DDC Thyroglobulin, Antigen,... · Immunology
Feb 1987 41d
SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT
K863842 · KLT Enzyme Immunoassay,... · Toxicology
Jan 1987 105d
GLUCOFACTS DATA MANAGEMENT SYSTEM
K861844 · JQP Calculator/data... · Chemistry
Aug 1986 91d
GLUCOFACTS DATA PRINTER
K861779 · JQP Calculator/data... · Chemistry
Aug 1986 92d
GLUCOMETER M BLOOD GULCOSE METER
K855202 · CGA Glucose Oxidase, Glucose · Chemistry
Jul 1986 188d
GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER
K861303 · CGA Glucose Oxidase, Glucose · Chemistry
Jul 1986 86d
CLINIFACTS 200 DATA MANAGEMENT SYSTEM
K861778 · JQP Calculator/data... · Chemistry
Jul 1986 55d
GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD
K855203 · FMK Single Use Only Blood... · General & Plastic Surgery
Feb 1986 47d
SERALYZER TOTAL BILIRUBIN CALIBRATORS
K855040 · JIS Calibrator, Primary · Chemistry
Jan 1986 36d
SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT
K852946 · DLZ Enzyme Immunoassay,... · Toxicology
Sep 1985 81d
TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE
K852611 · CDM Diazonium Colorimetry,... · Chemistry
Sep 1985 76d
GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT
K851703 · CGA Glucose Oxidase, Glucose · Chemistry
Aug 1985 121d
VISIDEX II REAGENT STRIPS
K852747 · Chemistry
Aug 1985 46d
OPTIMATE DIGOXIN TEST
K853021 · DPB Radioimmunoassay, Digoxin... · Toxicology
Aug 1985 20d

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