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
4201–4224 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 26, 1998
N-ASSAY L AST/GOT
K980902 · CIT
Crestat Diagnostics, Inc.
Chemistry · 16d
Cleared Mar 24, 1998
AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR...
K980574 · JLW
Alfa Biotech (Uk) , Ltd.
Chemistry · 35d
Cleared Mar 20, 1998
INFINITY AST REAGENT (PROCEDURE NO. 51)
K980666 · CIT
Sigma Diagnostics, Inc.
Chemistry · 28d
Cleared Mar 19, 1998
TYROSINE 50-HOUR REAGENT KIT
K970093 · CDR
Astoria-Pacific, Inc.
Chemistry · 433d
Cleared Mar 19, 1998
IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE
K980523 · CHL
Diametrics Medical, Inc.
Chemistry · 37d
Cleared Mar 18, 1998
ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K980173 · JHI
Beckman Instruments, Inc.
Chemistry · 57d
Cleared Mar 13, 1998
VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA
K973628 · JJF
Vital Scientific N.V.
Chemistry · 170d
Cleared Mar 13, 1998
PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG
K974009 · JHI
International Newtech Development, Inc.
Chemistry · 143d
Cleared Mar 11, 1998
CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30
K973999 · CGS
Diagnostic Chemicals , Ltd.
Chemistry · 141d
Cleared Mar 11, 1998
QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012
K980532 · LCX
Phamatech
Chemistry · 28d
Cleared Mar 10, 1998
GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
K980026 · CFR
Trace America, Inc.
Chemistry · 64d
Cleared Mar 06, 1998
RANDOX CREATININE
K973993 · CGX
Randox Laboratories, Ltd.
Chemistry · 136d
Cleared Mar 06, 1998
CARESIDE ANALYZER
K980056 · JJF
Exigent Diagnostics, Inc.
Chemistry · 59d
Cleared Mar 06, 1998
OSTEOMARK
K980518 · JMM
Ostex Intl., Inc.
Chemistry · 49d
Cleared Mar 06, 1998
AIMSTEP PREGNANCY
K980531 · JHI
Germaine Laboratories, Inc.
Chemistry · 23d
Cleared Mar 04, 1998
CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL...
K980514 · JJY
Medical Analysis Systems, Inc.
Chemistry · 22d
Cleared Mar 03, 1998
UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC...
K974721 · CGI
Bayer Corp.
Chemistry · 75d
Cleared Mar 03, 1998
VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER...
K980414 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 28d
Cleared Mar 03, 1998
CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI)
K980528 · MMI
Chiron Diagnostics Corp.
Chemistry · 20d
Cleared Mar 02, 1998
TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50
K973108 · CEK
Diagnostic Chemicals , Ltd.
Chemistry · 195d
Cleared Feb 25, 1998
CREATINE KINASE REAGENT
K980012 · JHX
Ac Biochemicals, Inc.
Chemistry · 54d
Cleared Feb 25, 1998
VITROS CHEMISTRY PRODUCTS CRBM SLIDES
K980283 · KLT
Johnson & Johnson Clinical...
Chemistry · 30d
Cleared Feb 25, 1998
LIQUICHEK CARDIAC MARKERS CONTROL LT
K980556 · JJT
Bio-Rad
Chemistry · 12d
Cleared Feb 24, 1998
VACUTAINER BRAND PPT PLASMA PREPARATION TUBE
K972075 · PJE
Becton Dickinson Vacutainer Systems
Chemistry · 266d