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
4729–4752 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 19, 1996
TSH (MICROWELL) ELISA
K962216 · JLW
Biomerica, Inc.
Chemistry · 101d
Cleared Sep 16, 1996
LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363
K961941 · JJY
Bio-Rad
Chemistry · 119d
Cleared Sep 13, 1996
DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR
K962629 · JIX
Casco Standards
Chemistry · 70d
Cleared Sep 11, 1996
THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST
K961629 · JLW
Teco Diagnostics
Chemistry · 138d
Cleared Sep 10, 1996
DSL DHEA-S-7
K962895 · JKC
Diagnostic Systems Laboratories, Inc.
Chemistry · 47d
Cleared Sep 10, 1996
ELECSYS CALCHECK T UPDATE
K963181 · JJX
Boehringer Mannheim Corp.
Chemistry · 27d
Cleared Sep 09, 1996
GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM
K955770 · JQB
Abaxis, Inc.
Chemistry · 263d
Cleared Sep 09, 1996
DSL ACTIVE FSH IRMA
K962118 · CGJ
Diagnostic Systems Laboratories, Inc.
Chemistry · 101d
Cleared Sep 09, 1996
STABILYPH UNASSAYED LIGAND ASSASY CONTROL, LEVELS 1, 2 AND 3
K963346 · JJY
Consolidated Technologies, Inc.
Chemistry · 14d
Cleared Sep 05, 1996
GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3
K960860 · JKA
Greiner America, Inc.
Chemistry · 188d
Cleared Sep 05, 1996
ELECT BLOOD GLUCOSE MONITORIG SYSTEM
K961985 · CGA
Selfcare, Inc.
Chemistry · 107d
Cleared Sep 03, 1996
LFS LIPOGEL ASSAY KIT
K960785 · JHO
Zaxis, Inc.
Chemistry · 190d
Cleared Aug 30, 1996
GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR
K960857 · JKA
Greiner America, Inc.
Chemistry · 182d
Cleared Aug 30, 1996
GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR
K960858 · JKA
Greiner America, Inc.
Chemistry · 182d
Cleared Aug 30, 1996
COBAS CORE IMMUNOCHEMISTRY SYSTEM
K962231 · JJE
Roche Diagnostic Systems, Inc.
Chemistry · 81d
Cleared Aug 30, 1996
VIDAS CREATINE KINASE MB ASSAY 30-421
K962549 · JHX
Biomerieux Vitek, Inc.
Chemistry · 63d
Cleared Aug 30, 1996
DSL 9100 IGF-II IRMA
K962758 · CFL
Diagnostic Systems Laboratories, Inc.
Chemistry · 45d
Cleared Aug 30, 1996
ELECSYS CALCHECK HCG
K963165 · JJX
Boehringer Mannheim Corp.
Chemistry · 16d
Cleared Aug 29, 1996
EZ SURE ONESTEP EARLY PREGNANCY TEST
K962580 · LCX
Excel Scientific, Inc.
Chemistry · 59d
Cleared Aug 29, 1996
IMMULITE ACTH CONTROL MODULE (LACCM)
K963240 · JJX
Diagnostic Products Corp.
Chemistry · 10d
Cleared Aug 27, 1996
DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05
K955880 · CIG
Diagnostic Chemicals , Ltd.
Chemistry · 243d
Cleared Aug 27, 1996
IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25
K961587 · JMO
Diagnostic Chemicals , Ltd.
Chemistry · 125d
Cleared Aug 27, 1996
ELECSYS CALCHECK FT3
K963163 · JJX
Boehringer Mannheim Corp.
Chemistry · 13d
Cleared Aug 27, 1996
ELECSYS CALCHECK FT4
K963164 · JJX
Boehringer Mannheim Corp.
Chemistry · 13d