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
4105–4128 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 25, 1998
CARESIDE ANALYZER
K981610 · CEO
Careside, Inc.
Chemistry · 56d
Cleared Jun 25, 1998
ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002
K981838 · JHI
Unotech Diagnostics, Inc.
Chemistry · 30d
Cleared Jun 24, 1998
OLYMPUS CALCIUM ARSENAZO III REAGENT
K982035 · CJY
Olympus Diagnostica GmbH
Chemistry · 14d
Cleared Jun 24, 1998
RAICHEM CO2 REAGENT
K982056 · KHS
Reagents Applications, Inc.
Chemistry · 15d
Cleared Jun 23, 1998
CARESIDE TOTAL BILIRUBIN
K981588 · CIG
Careside, Inc.
Chemistry · 50d
Cleared Jun 22, 1998
AMM
K981467 · JIF
Abbott Laboratories
Chemistry · 60d
Cleared Jun 22, 1998
ALKP
K981806 · CJE
Abbott Laboratories
Chemistry · 32d
Cleared Jun 19, 1998
URIC ACID
K981766 · CDO
Abbott Laboratories
Chemistry · 31d
Cleared Jun 17, 1998
VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE
K981013 · JKA
Becton Dickinson Vacutainer Systems
Chemistry · 91d
Cleared Jun 16, 1998
CA
K981578 · CJY
Abbott Laboratories
Chemistry · 43d
Cleared Jun 16, 1998
PHOS
K981759 · CEO
Abbott Laboratories
Chemistry · 28d
Cleared Jun 15, 1998
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT
K981632 · CIG
Roche Diagnostics/Boehringer Mannheim...
Chemistry · 38d
Cleared Jun 12, 1998
PHOS
K981118 · CEO
Abbott Laboratories
Chemistry · 77d
Cleared Jun 12, 1998
ALBG
K981758 · CIX
Abbott Laboratories
Chemistry · 24d
Cleared Jun 12, 1998
CLEANING SOLUTION (1) MODEL NUMBER A943-795, SALT BRIDGE SOLUTION MODEL...
K981795 · JIX
Thermo Bioanalysis Corp.
Chemistry · 22d
Cleared Jun 12, 1998
ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219
K981864 · JJX
Beckman Coulter, Inc.
Chemistry · 16d
Cleared Jun 11, 1998
HDL
K981580 · LBS
Abbott Laboratories
Chemistry · 38d
Cleared Jun 10, 1998
URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER
K980047 · KQO
Yeongdong Pharmaceutical Corp.
Chemistry · 155d
Cleared Jun 10, 1998
ACE T UPTAKE REAGENT TU CALIBRATORS
K981375 · KHQ
Schiapparelli Biosystems, Inc.
Chemistry · 55d
Cleared Jun 10, 1998
ACE T4 REAGENT T4 CALIBRATORS
K981377 · KLI
Schiapparelli Biosystems, Inc.
Chemistry · 55d
Cleared Jun 10, 1998
IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS)
K981495 · JHS
Diagnostic Products Corp.
Chemistry · 44d
Cleared Jun 09, 1998
OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER
K981743 · CKB
Olympus America, Inc.
Chemistry · 22d
Cleared Jun 08, 1998
AMY
K981216 · JFJ
Abbott Laboratories
Chemistry · 66d
Cleared Jun 08, 1998
IRON
K981581 · CFM
Abbott Laboratories
Chemistry · 35d