Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Chemistry ×
13,257 results
1105–1128 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Jul 31, 2013
ABL90 FLEX
K130144 · CHL
Radiometer Medical Aps
Chemistry · 190d
Cleared Jul 30, 2013
BROADMASTER HEALTHCARE SYSTEM
K130621 · NBW
Broadmaster Biotech Corporation
Chemistry · 144d
Cleared Jul 26, 2013
HBA1C CONTROL, LEVEL 1 AND LEVEL 2
K131999 · JJX
Randox Laboratories, Ltd.
Chemistry · 28d
Cleared Jul 26, 2013
CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST
K131931 · LCX
Chemtron Biotech, Inc.
Chemistry · 29d