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
5857–5880 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 15, 1993
KING DIAGNOSTICS CK REAGENT
K931326 · CGS
King Diagnostics, Inc.
Chemistry · 91d
Cleared Jun 15, 1993
ANALYZER: STAT PROFILE PLUS 10 ANALYZER
K931373 · JJY
Nova Biomedical Corp.
Chemistry · 89d
Cleared Jun 15, 1993
CHEMSTRIP URINE ANALYZER
K931602 · KQO
Boehringer Mannheim Corp.
Chemistry · 75d
Cleared Jun 09, 1993
MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM
K931148 · CHQ
Esa, Inc.
Chemistry · 96d
Cleared Jun 09, 1993
SAS PREGNANCY STRIP
K931302 · JHI
Sa Scientific, Inc.
Chemistry · 86d
Cleared Jun 07, 1993
OPUS MAGNUM ANALYZER
K926131 · KHO
Pb Diagnostic Systems, Inc.
Chemistry · 182d
Cleared Jun 07, 1993
UC QIK PREGNANCY TEST
K926500 · JHI
Eucardio Laboratory, Inc.
Chemistry · 160d
Cleared Jun 07, 1993
ACCESS THYROID UPTAKE ASSAY
K930010 · CEE
Bio-Rad Laboratories, Inc.
Chemistry · 154d
Cleared Jun 07, 1993
ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR
K930477 · JIS
Analytical Control Systems, Inc.
Chemistry · 129d
Cleared May 26, 1993
ACCESS(R) CORTISOL REAGENTS
K926322 · JFT
Bio-Rad Laboratories, Inc.
Chemistry · 161d
Cleared May 26, 1993
VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY
K926394 · CEP
Syva Co.
Chemistry · 156d
Cleared May 26, 1993
ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI
K926441 · KLT
Roche Diagnostic Systems, Inc.
Chemistry · 154d
Cleared May 26, 1993
COBAS CORE LH EIA
K930306 · CEP
Roche Diagnostic Systems, Inc.
Chemistry · 125d
Cleared May 26, 1993
BIOTROL AMYLASE CNPG3
K931141 · CIJ
Biotrol, USA, Inc.
Chemistry · 82d
Cleared May 26, 1993
CHECKMATE PLUS BLOOD GLUCOSE METER, TEST STRIP,ETC
K931188 · CGA
Cascade Medical, Inc.
Chemistry · 78d
Cleared May 26, 1993
KODAK EKTACHEM TOTAL IRON-BINDING CAPACITY KIT
K931493 · JMO
Eastman Kodak Company
Chemistry · 62d
Cleared May 20, 1993
COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS
K926443 · KHQ
Roche Diagnostic Systems, Inc.
Chemistry · 148d
Cleared May 20, 1993
RADIAS FREE T4 ENZYME IMMUNOASSAY
K931110 · CEC
Bio-Rad
Chemistry · 78d
Cleared May 13, 1993
VIDAS THYROXINE (T4) ASSAY (T4)
K926393 · KLI
Biomerieux Vitek, Inc.
Chemistry · 143d
Cleared May 12, 1993
AMYLASE METHOD/DIMENSION(R) CLINICAL CHEMISTRY SYS
K930489 · JJE
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 103d
Cleared May 12, 1993
DOCULMENT(R) CHEM VI CALIBRATION VERIF TEST SET
K931139 · JJY
Casco Standards
Chemistry · 68d
Cleared May 11, 1993
CLEARVIEW HCG
K924673 · JHI
Unipath , Ltd.
Chemistry · 237d
Cleared May 11, 1993
IN-VITRO DIAGNOSTIC REAGENT SET
K930074 · JGJ
Horizon Diagnostics, Inc.
Chemistry · 124d
Cleared May 11, 1993
DELFIA(R) HGH KIT
K930484 · CFL
Wallac OY
Chemistry · 102d