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

2905–2928 of 13,237

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

Cleared Oct 10, 2003

IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE

Diagnostic Products Corp.

Chemistry · 25d

Cleared Oct 08, 2003

CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS

Roche Diagnostics Corp.

Chemistry · 62d

Cleared Oct 07, 2003

I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3

I-Stat Corporation

Chemistry · 112d

Cleared Oct 06, 2003

ABBOTT ARCHITECT ESTRADIOL CALIBRATORS

Abbott Laboratories

Chemistry · 56d

Cleared Sep 30, 2003

Chemistry · 77d

Cleared Sep 30, 2003

SENOVA(R) BLOOD GLUCOSE MONITOR

Chdiagnostics, LLC

Chemistry · 85d

Cleared Sep 30, 2003

EXTENDED RANGE HS CRP KIT, CAT NO:9200

Reference Diagnostics, Inc.

Chemistry · 267d

Cleared Sep 29, 2003

VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS

Ortho-Clinical Diagnostics, Inc.

Chemistry · 181d

Cleared Sep 29, 2003

ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR

Elan Diagnostics

Chemistry · 270d

Cleared Sep 26, 2003

ATAC TOTAL BILIRUBIN REAGENT

Elan Diagnostics

Chemistry · 267d

Cleared Sep 22, 2003

ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST

ACON Laboratories, Inc.

Chemistry · 39d

Cleared Sep 22, 2003

Tomen America, Inc.

Chemistry · 123d

Cleared Sep 17, 2003

AKERS LABORATORIES INC. BLOOD CELL SEPARATOR

Akers Laboratories, Inc.

Chemistry · 187d

Cleared Sep 12, 2003

ACCU-CHEK ADVANTAGE SYSTEM

Roche Diagnostics Corp.

Chemistry · 24d

Cleared Sep 12, 2003

S-MONOVETTE EDTA K2-GEL

Chemistry · 135d

Cleared Sep 09, 2003

BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER

Bayer Healthcare, LLC

Chemistry · 25d

Cleared Sep 09, 2003

AUDIT MICROCONTROLS MICROFD BNP CONTROL

Aalto Scientific, Ltd.

Chemistry · 62d

Cleared Sep 05, 2003

CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY

Access Bio Incorporate

Chemistry · 52d

Cleared Sep 05, 2003

CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)

Cholestech Corp.

Chemistry · 66d

Cleared Sep 04, 2003

ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY

Bayer Diagnostics Corp.

Chemistry · 80d

Cleared Sep 03, 2003

HOMOCYSTEINE MICROTITER PLATE ASSAY

Diazyme Laboratories

Chemistry · 65d

Cleared Sep 02, 2003

I-STAT CARDIAC TROPONIN (CTNI) TEST

I-Stat Corporation

Chemistry · 90d

Cleared Sep 02, 2003

Chemistry · 193d

Cleared Aug 28, 2003

ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL

Bionostics, Inc.

Chemistry · 17d