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

4993–5016 of 13,237

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

Cleared Dec 21, 1995

CEDIA T UPTAKE ASSAY

Boehringer Mannheim Corp.

Chemistry · 63d

Cleared Dec 21, 1995

IMMULITE SHBG (MODIFICATION)

Diagnostic Products Corp.

Chemistry · 59d

Cleared Dec 20, 1995

AMERLITE MAB FT4 ASSAY

Kodak Clinical Diagnostics, Ltd.

Chemistry · 43d

Cleared Dec 20, 1995

DOCUMENT TDM ULTRA UNASSAYED CONTROL

Casco Standards

Chemistry · 37d

Cleared Dec 20, 1995

TOTAL BILIRUBIN PROCEDURE

Data Medical Associates, Inc.

Chemistry · 30d

Cleared Dec 15, 1995

AIA-PACK CORT ASSAY

Tosoh Medics, Inc.

Chemistry · 74d

Cleared Dec 13, 1995

CIBA CORNING ACS ESTRADIOL-6 ASSAY

Ciba Corning Diagnostics Corp.

Chemistry · 62d

Cleared Dec 13, 1995

QUIX RAPID PREGNANCY STRIP TEST

Guardian Scientific, Corp.

Chemistry · 43d

Cleared Dec 11, 1995

AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)

Emd Chemicals, Inc.

Chemistry · 255d

Cleared Dec 11, 1995

HDL PRECIPITATING REAGENT

Schiapparelli Biosystems, Inc.

Chemistry · 96d

Cleared Dec 11, 1995

BIONIKE A/Q PREGNANCY TEST

Bionike Laboratories, Inc.

Chemistry · 47d

Cleared Dec 11, 1995

CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT

Alko Diagnostic Corp.

Chemistry · 28d

Cleared Dec 06, 1995

OSOM HCG COMBO TEST

Wyntek Diagnostics, Inc.

Chemistry · 23d

Cleared Dec 05, 1995

ACCESS CORTISOL ASSAY (MODIFICATION)

Bio-Rad Laboratories, Inc.

Chemistry · 64d

Cleared Dec 04, 1995

SENDX 100 PH, BLOOD GAS & ELECTROLYTE ANALYSIS SYSTEM

Cirrus Medical,Inc.

Chemistry · 68d

Cleared Dec 04, 1995

ANTHOS 2010 READER

Anthos Labtec, Inc.

Chemistry · 28d

Cleared Nov 30, 1995

STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION)

Nova Biomedical Corp.

Chemistry · 63d

Cleared Nov 29, 1995

COAT-A-COUNT DIRECT ANDROSTENEDIONE

Diagnostic Products Corp.

Chemistry · 44d

Cleared Nov 28, 1995

VACUTAINER BRAND PST PLASMA SEPARATION TUBE

Becton Dickinson Vacutainer Systems

Chemistry · 57d

Cleared Nov 28, 1995

LIQUICHEK ETHANOL/AMMONIA CONTROL

Chemistry · 26d

Cleared Nov 27, 1995

ALKALINE PHOSPHATASE REAGENT SYSTEM

Medical Diagnostic Technologies, Inc.

Chemistry · 164d

Cleared Nov 24, 1995

CHOLESTECH LDX SYSTEM

Cholestech Corp.

Chemistry · 66d

Cleared Nov 22, 1995

BIOCIRCUITS IOS (IN-OFFICE SYSTEM)

Biocircuits Corp.

Chemistry · 160d

Cleared Nov 21, 1995

ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS

Boehringer Mannheim Corp.

Chemistry · 155d