FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×

13,237 results

2857–2880 of 13,237

Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry

Cleared Dec 19, 2003

QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH...

Instrumentation Laboratory CO

Chemistry · 113d

Cleared Dec 19, 2003

BAYER CLINITEK STATUS ANALYZER

Bayer Healthcare, LLC

Chemistry · 178d

Cleared Dec 19, 2003

FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES...

Abbott Diabetes Care, Inc.

Chemistry · 242d

Cleared Dec 18, 2003

BTG SMARTEST GLUCOSE TEST SYSTEM

Chemistry · 170d

Cleared Dec 17, 2003

LIGHTCYCLER INSTRUMENT VERSION 1.2

Roche Diagnostics Corp.

Chemistry · 19d

Cleared Dec 17, 2003

BAYER RAPIDLAB 1200 SYSTEM

Bayer Healthcare, LLC

Chemistry · 212d

Cleared Dec 16, 2003

BAYER SPECIAL CHEMISTRY CALIBRATORS

Bayer Diagnostics Corp.

Chemistry · 55d

Cleared Dec 15, 2003

PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS

Roche Diagnostics Corp.

Chemistry · 62d

Cleared Dec 12, 2003

IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER

Diagnostic Products Corp.

Chemistry · 67d

Cleared Dec 12, 2003

MISSION CONTROLS

Diamond Diagnostics, Inc.

Chemistry · 74d

Cleared Dec 05, 2003

HDL-CHOLESTEROL PLUS 2ND GENERATION

Roche Diagnostics Corp.

Chemistry · 18d

Cleared Dec 04, 2003

RANDOX RX DAYTONA

Randox Laboratories, Ltd.

Chemistry · 365d

Cleared Dec 02, 2003

QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945

Chemistry · 40d

Cleared Nov 24, 2003

ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER

Roche Diagnostics Corp.

Chemistry · 12d

Cleared Nov 21, 2003

ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP

ACON Laboratories, Inc.

Chemistry · 53d

Cleared Nov 21, 2003

UNIMARK HOME PREGNANCY TEST DEVICE

Biotech Atlantic, Inc.

Chemistry · 57d

Cleared Nov 21, 2003

OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071

Olympus America, Inc.

Chemistry · 85d

Cleared Nov 20, 2003

MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)

Roche Diagnostics Corp.

Chemistry · 15d

Cleared Nov 18, 2003

GLUCOSE TOLERANCE BEVERAGE

Perk Scientific, Inc.

Chemistry · 74d

Cleared Nov 17, 2003

ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005

Unotech Diagnostics, Inc.

Chemistry · 54d

Cleared Nov 14, 2003

BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM

Bayer Diagnostics Corp.

Chemistry · 49d

Cleared Nov 14, 2003

OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR,...

Olympus America, Inc.

Chemistry · 197d

Cleared Nov 12, 2003

ELECSYS PROBNP IMMUNOASSAY

Roche Diagnostics Corp.

Chemistry · 77d

Cleared Nov 12, 2003

GOOD MORNING TEST

Standard Diagnostics, Inc.

Chemistry · 155d