Medical Device Manufacturer · US , Bethlehem , PA

Solarcare Technologies Corp,Inc.

28 submissions · 28 cleared · Since 1991
28
Total
28
Cleared
0
Denied

Solarcare Technologies Corp,Inc. — FDA 510(k) Submissions

Solarcare Technologies Corp,Inc. has submitted 28 FDA 510(k) premarket notifications since 1991, of which 28 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Unit, Cryosurgical, Accessories, Enzyme Immunoassay, Opiates, Enzyme Immunoassay, Amphetamine, Enzyme Immunoassay, Cocaine, Automated Urinalysis System . Use the specialty filter in the sidebar to narrow results.

28 devices
1–25 of 28
STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY
K954326 · JIT Calibrator, Secondary · Chemistry
Jul 1996 312d
STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY
K954156 · KQO Automated Urinalysis System · Chemistry
Jul 1996 321d
STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
K955905 · CEK Biuret (colorimetric),... · Chemistry
May 1996 153d
STC DIAGNOSTICS AUTO-LYTE PH ASSAY
K954158 · KQO Automated Urinalysis System · Chemistry
Apr 1996 238d
STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION
K940048 · DLJ Calibrators, Drug Specific · Toxicology
Mar 1996 804d
STC DIAGNOSTICS LSD MICRO-PLATE EIA
K954073 · DLB Radioimmunoassay, Lsd... · Toxicology
Nov 1995 91d
STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY
K954266 · CGX Alkaline Picrate,... · Chemistry
Oct 1995 31d
OPIATES MICRO-PLATE ASSAY
K935565 · DJG Enzyme Immunoassay, Opiates · Toxicology
Jul 1995 603d
AMPHETAMINES MICRO-PLATE EIA
K935573 · DKZ Enzyme Immunoassay,... · Toxicology
Jul 1995 603d
STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA
K950308 · JXS Block, Cutting, Ent, Sterile · Toxicology
Apr 1995 79d
AUTO-LYTE METHADONE DIA
K944056 · DJR Enzyme Immunoassay,... · Toxicology
Dec 1994 132d
STC DIAGNOSTICS AUTO-LYTE BENZODIAZEPINES EIA
K934869 · JXM Enzyme Immunoassay,... · Toxicology
Nov 1993 41d
HISTOFREEZER
K931299 · GEH Unit, Cryosurgical,... · General & Plastic Surgery
Aug 1993 149d
SOLARCARE TECHNOLOGIES CORP. MICROPLATE AMP. ASSAY
K931498 · DKZ Enzyme Immunoassay,... · Toxicology
Jul 1993 117d
STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY
K931516 · DIC Alcohol Dehydrogenase,... · Toxicology
Jul 1993 115d
STC DIAGNOSTICS AUTO-LYTE CANNABINOIDS EIA
K930654 · LDJ Enzyme Immunoassay,... · Toxicology
May 1993 86d
STC DIAGNOSTICS AUTO-LYTE AMPHETAMINES EIA
K930690 · DKZ Enzyme Immunoassay,... · Toxicology
Apr 1993 65d
NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY
K923532 · JLW Radioimmunoassay,... · Chemistry
Mar 1993 239d
NAT. SCREENING INSTITUTE MICRO-PLATE FREE T4 ASSAY
K925649 · CEC Radioimmunoassay, Free... · Chemistry
Mar 1993 112d
HISTOFREEZER
K924114 · GEH Unit, Cryosurgical,... · General & Plastic Surgery
Feb 1993 184d
MICROPLATE CANNABINOIDS ASSAY
K924815 · LDJ Enzyme Immunoassay,... · Toxicology
Jan 1993 123d
SOLARCARE TECHNOLOGIES CORP. MICRO-PLATE PCP ASSAY
K924751 · LCM Enzyme Immunoassay,... · Toxicology
Dec 1992 79d
STC DIAGNOSTICS AUTO-LYTE(TM) PCP EIA
K924462 · LCM Enzyme Immunoassay,... · Toxicology
Nov 1992 61d
MICRO-PLATE OPIATES ASSAY
K924446 · DJG Enzyme Immunoassay, Opiates · Toxicology
Oct 1992 44d
STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIA
K921140 · JXO Enzyme Immunoassay, Cocaine · Toxicology
Aug 1992 163d
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