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
4081–4104 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 22, 1998
CREA
K981799 · CGX
Abbott Laboratories
Chemistry · 62d
Cleared Jul 22, 1998
ALBP
K981814 · CJW
Abbott Laboratories
Chemistry · 61d
Cleared Jul 22, 1998
AMM
K981920 · JIF
Abbott Laboratories
Chemistry · 51d
Cleared Jul 22, 1998
DBIL
K981943 · CIG
Abbott Laboratories
Chemistry · 49d
Cleared Jul 22, 1998
AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR
K981978 · MRR
Pointe Scientific, Inc.,
Chemistry · 47d
Cleared Jul 22, 1998
MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)
K982277 · CHL
Nova Biomedical Corp.
Chemistry · 23d
Cleared Jul 22, 1998
CHEM-CHEX STAT (NEW)
K982290 · JJY
Streck Laboratories, Inc.
Chemistry · 23d
Cleared Jul 14, 1998
CARESIDE HDL-CHOLESTEROL
K981899 · LBS
Exigent Diagnostics, Inc.
Chemistry · 43d
Cleared Jul 14, 1998
ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K982250 · CEC
Beckman Instruments, Inc.
Chemistry · 18d
Cleared Jul 09, 1998
AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL,...
K981706 · JIX
Abbott Laboratories
Chemistry · 56d
Cleared Jul 09, 1998
VIGIL PROTEIN CONTROL
K982224 · JJY
Beckman Coulter, Inc.
Chemistry · 15d
Cleared Jul 07, 1998
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN...
K981883 · CIG
Boehringer Mannheim Corp.
Chemistry · 39d
Cleared Jul 06, 1998
CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST
K981882 · MMI
Princeton BioMeditech Corp.
Chemistry · 39d
Cleared Jun 29, 1998
BIOSTRIDE FREE T4 EIA TEST KIT
K981243 · CEC
Biostride Diagnostics, Inc.
Chemistry · 84d
Cleared Jun 29, 1998
AST/SGOT LIQUID REAGENT - KINETIC METHOD
K981650 · CIT
Teco Diagnostics
Chemistry · 49d
Cleared Jun 29, 1998
CHOL
K981652 · CHH
Abbott Laboratories
Chemistry · 49d
Cleared Jun 29, 1998
HICHEM PHOSPHORUS REAGENT KIT
K981769 · CEO
Elan Pharma, Inc.
Chemistry · 41d
Cleared Jun 29, 1998
AST
K981843 · CIT
Abbott Laboratories
Chemistry · 34d
Cleared Jun 29, 1998
URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2
K981933 · JJW
Medical Analysis Systems, Inc.
Chemistry · 27d
Cleared Jun 29, 1998
I-STAT LACTATE TEST
K982071 · KHP
I-Stat Corp.
Chemistry · 17d
Cleared Jun 25, 1998
CLEARPLAN EASY OVULATION TEST
K981271 · CEP
Unipath , Ltd.
Chemistry · 79d
Cleared Jun 25, 1998
BIOSIGN HCG I - ONE STEP PREGNANCY TEST
K981443 · JHI
Princeton BioMeditech Corp.
Chemistry · 64d
Cleared Jun 25, 1998
CHOL
K981476 · CHH
Abbott Laboratories
Chemistry · 62d
Cleared Jun 25, 1998
CARESIDE URIC ACID
K981604 · KNK
Careside, Inc.
Chemistry · 58d