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
4057–4080 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 19, 1998
SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT
K982608 · CKG
Sangui Biotech, Inc.
Chemistry · 23d
Cleared Aug 18, 1998
OLYMPUS SERUM PROTEIN MULTICALIBRATOR,
K981854 · JIT
Olympus Diagnostica GmbH
Chemistry · 84d
Cleared Aug 18, 1998
QUICK & SURE ONESTEP HOME PREGNANCY TEST
K981892 · LCX
Abacus Diagnostics
Chemistry · 81d
Cleared Aug 18, 1998
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT
K982251 · CDO
Sigma Diagnostics, Inc.
Chemistry · 53d
Cleared Aug 13, 1998
GLYCACOR
K980888 · LCP
Exocell, Inc.
Chemistry · 157d
Cleared Aug 13, 1998
PYRILINKS-D ASSAY KIT
K981364 · JMM
Metra Biosystems, Inc.
Chemistry · 120d
Cleared Aug 13, 1998
PREALBUMIN CALIBRATOR
K982292 · JIT
Dade Behring, Inc.
Chemistry · 44d
Cleared Aug 12, 1998
MICROALBUSTIX REAGENT STRIPS
K982219 · JIR
Bayer Corp.
Chemistry · 49d
Cleared Aug 12, 1998
VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III
K982649 · DIF
Ortho-Clinical Diagnostics, Inc.
Chemistry · 13d
Cleared Aug 06, 1998
B2-MICROGLOBULIN CONTROL SET SERUM
K982471 · JJX
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Aug 05, 1998
SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT
K982236 · CDQ
Sigma Diagnostics, Inc.
Chemistry · 41d
Cleared Aug 05, 1998
DADE TRU-LIQUID CARDIAC CONTROL
K982591 · JJX
Dade Behring, Inc.
Chemistry · 12d
Cleared Aug 03, 1998
ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE)
K981181 · CHH
Actimed Laboratories, Inc.
Chemistry · 124d
Cleared Aug 03, 1998
DIRECT HDL
K981224 · LBS
Abbott Laboratories
Chemistry · 122d
Cleared Aug 03, 1998
DIRECT LDL
K981303 · MRR
Abbott Laboratories
Chemistry · 115d
Cleared Jul 30, 1998
SENSOREX BLOOD GLUCOSE MONITORING SYSTEM
K980573 · CGA
Chronimed, Inc.
Chemistry · 163d
Cleared Jul 30, 1998
UIBC
K982041 · JMO
Abbott Laboratories
Chemistry · 50d
Cleared Jul 30, 1998
DIRECT HDL-CHOLESTROL LIQUID
K982341 · LBS
Randox Laboratories, Ltd.
Chemistry · 38d
Cleared Jul 29, 1998
HICHEM CALCIUM REAGENT KIT
K981794 · CJY
Hichem Diagnostics
Chemistry · 69d
Cleared Jul 28, 1998
UREA
K981918 · CDQ
Abbott Laboratories
Chemistry · 57d
Cleared Jul 24, 1998
CARESIDE ANALYZER
K982118 · CHH
Exigent Diagnostics, Inc.
Chemistry · 51d
Cleared Jul 22, 1998
BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY...
K981444 · JHI
Princeton BioMeditech Corp.
Chemistry · 91d
Cleared Jul 22, 1998
MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220
K981493 · CHH
Polymer Technology Systems, Inc.
Chemistry · 86d
Cleared Jul 22, 1998
TIBC
K981654 · JMO
Abbott Laboratories
Chemistry · 72d