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
4177–4200 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 23, 1998
ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED)
K981221 · CIT
Abbott Laboratories
Chemistry · 20d
Cleared Apr 23, 1998
ASPARTATE AMINOTRANSFERASE (AST)
K981225 · CIT
Abbott Laboratories
Chemistry · 20d
Cleared Apr 23, 1998
ELECSYS CALCHECK CA 125II
K981278 · JJX
Roche Diagnostics GmbH
Chemistry · 15d
Cleared Apr 21, 1998
INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)
K980667 · CHH
Sigma Diagnostics, Inc.
Chemistry · 60d
Cleared Apr 21, 1998
ILAB 600 CLINICAL CHEMISTRY SYSTEM
K980757 · CGZ
Instrumentation Laboratory CO
Chemistry · 53d
Cleared Apr 21, 1998
HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51
K980770 · LBR
Diagnostic Chemicals , Ltd.
Chemistry · 60d
Cleared Apr 21, 1998
PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES
K981035 · JKA
Sims Portex, Inc.
Chemistry · 33d
Cleared Apr 21, 1998
QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3
K981339 · JJY
Consolidated Technologies, Inc.
Chemistry · 8d
Cleared Apr 16, 1998
ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST
K980736 · JHI
Acon Laboratories Co.
Chemistry · 50d
Cleared Apr 16, 1998
STRATUS CS CKMB CALPAK
K981097 · JIT
Dade Behring, Inc.
Chemistry · 21d
Cleared Apr 16, 1998
STRATUS CS TROP CALPAK
K981100 · JIT
Dade Behring, Inc.
Chemistry · 21d
Cleared Apr 16, 1998
UREA NITROGEN (BUN) LIQUID REAGENT
K981106 · CDQ
Teco Diagnostics
Chemistry · 21d
Cleared Apr 16, 1998
AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST
K981165 · JHI
Germaine Laboratories, Inc.
Chemistry · 16d
Cleared Apr 15, 1998
MACRALP(A) ENZYME IMMUNOASSAY KIT
K971157 · JHO
Strategic Diagnostics, Inc.
Chemistry · 383d
Cleared Apr 15, 1998
UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD
K980525 · KWX
Marukin Shoyu Co., Ltd.
Chemistry · 63d
Cleared Apr 15, 1998
NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER
K980991 · CHL
Nova Biomedical Corp.
Chemistry · 29d
Cleared Apr 15, 1998
STRATUS CS MYO CALPAK
K981101 · JIT
Dade Behring, Inc.
Chemistry · 20d
Cleared Apr 09, 1998
ONE STEP MIDSTREAM HCG PREGNANCY TEST
K974059 · LCX
International Newtech Development, Inc.
Chemistry · 164d
Cleared Apr 09, 1998
MINISTRIP/ SERUM AND URINE COMBO HCG TEST
K974060 · JHI
International Newtech Development, Inc.
Chemistry · 164d
Cleared Apr 03, 1998
BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS
K980819 · CEC
Biocircuits Corp.
Chemistry · 31d
Cleared Apr 02, 1998
QUICKCARD PRO HCG TEST, MODEL 9008
K980896 · JHI
Phamatech
Chemistry · 24d
Cleared Apr 01, 1998
AEROSET SYSTEM
K980367 · CGZ
Abbott Laboratories
Chemistry · 62d
Cleared Mar 30, 1998
CARESIDE CREATININE
K980043 · JFY
Exigent Diagnostics, Inc.
Chemistry · 83d
Cleared Mar 26, 1998
N-ASSAY CPK-L
K980900 · CGS
Crestat Diagnostics, Inc.
Chemistry · 16d