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
1081–1104 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 17, 2013
ABL90 FLEX ANALYZER
K131988 · CHL
Radiometer Medical Aps
Chemistry · 81d
Cleared Sep 13, 2013
ADVIA CENTAUR FT4, ADVIA CENTAUR T4
K132249 · CEC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 56d
Cleared Sep 10, 2013
FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
K123567 · LCX
Church & Dwight Co., Inc.
Chemistry · 294d
Cleared Sep 06, 2013
LIAISON XL HCG
K131037 · DHA
DiaSorin, Inc.
Chemistry · 144d
Cleared Sep 05, 2013
LIAISON 25 TOTAL-D
K132492 · MRG
DiaSorin, Inc.
Chemistry · 27d
Cleared Aug 30, 2013
ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
K131363 · NBW
Cilag GmbH International
Chemistry · 109d
Cleared Aug 26, 2013
FIRST RESPONSE EARLY RESULT PREGNANCY TEST
K123436 · LCX
Church & Dwight Co., Inc.
Chemistry · 292d
Cleared Aug 23, 2013
DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM
K130244 · NBW
Delbio Incorporation
Chemistry · 204d
Cleared Aug 23, 2013
VANISHPOINT BLOOD COLLECTION SET
K122355 · JKA
Retractable Technologies, Inc.
Chemistry · 385d
Cleared Aug 22, 2013
OPTI CCA-TS2
K131126 · CHL
Opti Medical Systems, Inc.
Chemistry · 122d
Cleared Aug 21, 2013
CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM
K130696 · NBW
I-Sens, Inc.
Chemistry · 160d
Cleared Aug 20, 2013
LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM
K123563 · DOF
Magellan Diagnostics
Chemistry · 274d
Cleared Aug 20, 2013
THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY
K122766 · OUF
Microgenics Corp.
Chemistry · 344d
Cleared Aug 19, 2013
ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT...
K131488 · CIX
Alfa Wassermann Diagnostics...
Chemistry · 88d
Cleared Aug 15, 2013
TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL...
K132072 · NBW
Nipro Diagnostics, Inc.
Chemistry · 43d
Cleared Aug 15, 2013
ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT
K131351 · CJE
Alfa Wassermann Diagnostic...
Chemistry · 97d
Cleared Aug 15, 2013
EBCHEK BLOOD GLUCOSE MONITORING SYSTEM
K122181 · NBW
Visgeneer, Inc.
Chemistry · 388d
Cleared Aug 14, 2013
ACE -GT REAGENT
K131515 · KLI
Alfa Wassermann
Chemistry · 78d
Cleared Aug 09, 2013
ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM
K131419 · NBW
I-Sens, Inc.
Chemistry · 85d
Cleared Aug 09, 2013
ACCU-CHEK AVIVA PLUS TEST STRIP
K131029 · NBW
Roche Diagnostics Operations, Inc.
Chemistry · 119d
Cleared Aug 09, 2013
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY
K130685 · JFJ
Hitachi Chemical Diagnostics, Inc.
Chemistry · 149d
Cleared Aug 08, 2013
COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY
K121610 · PDJ
Roche Diagnostics Operations
Chemistry · 433d
Cleared Aug 02, 2013
SOFIA(R) HCG FIA
K131166 · JHI
Quidel Corp.
Chemistry · 100d
Cleared Jul 31, 2013
GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE...
K130181 · NBW
Infopia Co, Ltd.
Chemistry · 187d