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

3937–3960 of 13,237

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

Cleared Jan 28, 1999

RDI DIRECT LDL CHOLESTEROL TEST

Reference Diagnostics, Inc.

Chemistry · 72d

Cleared Jan 28, 1999

Abbott Laboratories

Chemistry · 94d

Cleared Jan 26, 1999

ABBOTT LIQUID LIPIDS CHEMISTRY, MODEL #'S 3E18-01, 3E19-01

Chemistry · 7d

Cleared Jan 26, 1999

ABBOTT LIQUID PEDIATRIC CHEMISTRY CONTROL, MODEL # 4E37-01, 4E38-01

Chemistry · 7d

Cleared Jan 25, 1999

VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS

Ortho-Clinical Diagnostics, Inc.

Chemistry · 17d

Cleared Jan 25, 1999

ABBOTT IMMUNOASSAY-MCC (LIQUID) CONTROL, MODEL NUMBER 6E20-10

Chemistry · 21d

Cleared Jan 20, 1999

MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR

Boehringer Mannheim Corp.

Chemistry · 40d

Cleared Jan 20, 1999

WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR

Wako Chemicals USA, Inc.

Chemistry · 63d

Cleared Jan 15, 1999

WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR

Wako Chemicals USA, Inc.

Chemistry · 58d

Cleared Jan 13, 1999

CARESIDE ALKALINE PHOSPHATASE

Chemistry · 8d

Cleared Jan 13, 1999

ORAL-EZE ORAL FLUID COLLECTION SYSTEM

Osborn Laboratories, Inc.

Chemistry · 37d

Cleared Jan 13, 1999

WAKO L-TYPE AMYLASE

Wako Chemicals USA, Inc.

Chemistry · 51d

Cleared Jan 13, 1999

STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK

Dade Behring, Inc.

Chemistry · 58d

Cleared Jan 11, 1999

DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT...

Dade Behring, Inc.

Chemistry · 73d

Cleared Jan 06, 1999

DUAL VIAL CREATININE REAGENT

Intersect Systems, Inc.

Chemistry · 62d

Cleared Jan 06, 1999

NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM

Radiometer America, Inc.

Chemistry · 139d

Cleared Dec 31, 1998

'RAPID DRUG SCREEN' 9-PANEL

American Bio Medica Corp.

Chemistry · 66d

Cleared Dec 29, 1998

VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY

Ortho-Clinical Diagnostics, Inc.

Chemistry · 50d

Cleared Dec 28, 1998

GREINER VACUETTE BLOOD COLLECTION TUBE

Greiner Meditech, Inc.

Chemistry · 53d

Cleared Dec 23, 1998

6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497

Thermo Bioanalysis Corp.

Chemistry · 15d

Cleared Dec 23, 1998

AIA-PACK TROPONIN I ASSAY

Tosoh Medics, Inc.

Chemistry · 16d

Cleared Dec 23, 1998

SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2

Beckman Coulter, Inc.

Chemistry · 42d

Cleared Dec 22, 1998

ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05

Chemistry · 19d

Cleared Dec 22, 1998

ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05

Chemistry · 19d