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
7825–7848 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 01, 1988
SPECIFIC CHEMISTRY ANALYZER
K882081 · JJE
The Rupp & Bowman Co.
Chemistry · 45d
Cleared Jul 01, 1988
BIOTROL TOTAL PROTEIN H.P.
K882189 · CEK
Biotrol, USA, Inc.
Chemistry · 38d
Cleared Jul 01, 1988
TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT
K882343 · CHP
Terumo Medical Corp.
Chemistry · 24d
Cleared Jun 28, 1988
JAYCO HYDROGEN MONITOR
K882499 · NRH
Enteron, Inc.
Chemistry · 11d
Cleared Jun 24, 1988
GDS ENZYMATIC SALICYLATE REAGENT
K882038 · DKJ
Gds Technology, LLC
Chemistry · 39d
Cleared Jun 24, 1988
TOTAL PROTEIN/ALBUMIN STANDARD
K882116 · JIX
Verichem Laboratories, Inc.
Chemistry · 36d
Cleared Jun 24, 1988
DELFIA ESTRADIOL KIT
K882173 · CHP
Pharmacia, Inc.
Chemistry · 31d
Cleared Jun 20, 1988
HELENA REP GEL PROCESSOR
K882163 · JJN
Helena Laboratories
Chemistry · 27d
Cleared Jun 16, 1988
BIOTROL CREATININE H.P. REAGENT
K881856 · CGX
Biotrol, USA, Inc.
Chemistry · 44d
Cleared Jun 15, 1988
CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM
K880353 · GKR
Ciba Corning Diagnostics Corp.
Chemistry · 141d
Cleared Jun 15, 1988
EASY WASHER II MICROPLATE WASHER
K881797 · JJQ
Slt Labinstruments, Inc.
Chemistry · 49d
Cleared Jun 15, 1988
BICARBONATE (CO2) REAGENT-2 VIAL
K881938 · KHS
Trace Scientific , Ltd.
Chemistry · 37d
Cleared Jun 10, 1988
SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD
K864159 · CHH
Chem-Elec, Inc.
Chemistry · 596d
Cleared Jun 10, 1988
RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID)
K880576 · CJY
Reagents Applications, Inc.
Chemistry · 121d
Cleared Jun 10, 1988
HDL CHOLESTEROL KIT
K881244 · LBR
Trace Scientific , Ltd.
Chemistry · 79d
Cleared Jun 10, 1988
DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET
K881773 · JJR
Casco Standards
Chemistry · 45d
Cleared Jun 10, 1988
EMIT CONVENIENCE PACK: T-UPTAKE ASSAY
K881855 · KHQ
Syva Co.
Chemistry · 38d
Cleared Jun 10, 1988
COBAS EIA(TM) PHOTOMETER
K881877 · JJQ
Roche Diagnostic Systems, Inc.
Chemistry · 37d
Cleared Jun 10, 1988
IQ HDL CHOLESTEROL
K881891 · LBS
Bd Becton Dickinson Vacutainer...
Chemistry · 36d
Cleared Jun 08, 1988
AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT
K881355 · JHI
Amersham Corp.
Chemistry · 51d
Cleared Jun 08, 1988
PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM
K881774 · CFT
Bd Becton Dickinson Vacutainer...
Chemistry · 43d
Cleared Jun 08, 1988
IMPRES-MB
K881801 · JHW
Intl. Immunoassay Laboratories, Inc.
Chemistry · 42d
Cleared Jun 07, 1988
AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200
K880654 · JIW
American Research Products Co.
Chemistry · 111d
Cleared Jun 07, 1988
BILIRUBIN (DIRECT)
K881172 · CIG
Tech-Co, Inc.
Chemistry · 81d