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
3505–3528 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 22, 2001
EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS
K003341 · KLB
Syva Co., Dade Behring, Inc.
Chemistry · 89d
Cleared Jan 22, 2001
GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM
K002624 · CGA
Apex BioTechnology Corp.
Chemistry · 152d
Cleared Jan 22, 2001
GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM
K002621 · CGA
Apex BioTechnology Corp.
Chemistry · 152d
Cleared Jan 17, 2001
LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901
K003583 · NDW
Trace America, Inc.
Chemistry · 58d
Cleared Jan 17, 2001
ELECSYS DHEA-S
K003174 · JKC
Roche Diagnostics Corp.
Chemistry · 99d
Cleared Jan 17, 2001
FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT
K002638 · CKG
Future Diagnostics B.V.
Chemistry · 146d
Cleared Jan 12, 2001
GENUA MENOPAUSE MONITOR TEST KIT
K002450 · CGJ
Genua 1944, Inc.
Chemistry · 156d
Cleared Dec 22, 2000
EHC400 DESKTOP PATIENT STATION
K003257 · CGA
Cybercare Technologies, Inc.
Chemistry · 65d
Cleared Dec 22, 2000
SYNCHRON SYSTEMS AMMONIA REAGENT
K003196 · JIF
Beckman Coulter, Inc.
Chemistry · 71d
Cleared Dec 20, 2000
ELECSYS DHEA-S CALCHECK
K003772 · JJX
Roche Diagnostics Corp.
Chemistry · 14d
Cleared Dec 20, 2000
CONFORMANCE CHEMISTRY CONTROL C3
K003716 · JJY
Consolidated Technology
Chemistry · 19d
Cleared Dec 19, 2000
BAYER RAPIDPOINT 400 SYSTEM
K002738 · CHL
Bayer Corp.
Chemistry · 109d
Cleared Dec 19, 2000
APPRAISE URINE MICROALBUMIN COLLECTION KIT
K002156 · CGX
Osborn Group, Inc.
Chemistry · 155d
Cleared Dec 18, 2000
MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
K003721 · JJE
Olympus America, Inc.
Chemistry · 14d
Cleared Dec 18, 2000
ROCHE DIAGNOSTICS CK-MB
K003158 · JHW
Roche Diagnostics Corp.
Chemistry · 69d
Cleared Dec 18, 2000
SATURN BLOOD GLUCOSE MONITORING TEST STRIP
K001441 · CGA
Lifescan, Inc.
Chemistry · 224d
Cleared Dec 14, 2000
CREATININE
K003247 · CGX
Jas Diagnostics, Inc.
Chemistry · 58d
Cleared Dec 14, 2000
ELECSYS HCG AND BETA TEST SYSTEM
K003178 · DHA
Roche Diagnostics Corp.
Chemistry · 64d
Cleared Dec 05, 2000
ALBUMIN
K003327 · CIX
Jas Diagnostics, Inc.
Chemistry · 42d
Cleared Dec 05, 2000
ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100
K002128 · NDR
Diagnostic Systems Laboratories, Inc.
Chemistry · 144d
Cleared Dec 05, 2000
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001
K000582 · LFR
Abbott Diabetes Care, Inc.
Chemistry · 287d
Cleared Nov 30, 2000
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623
K003242 · JJS
Bio-Rad
Chemistry · 44d
Cleared Nov 30, 2000
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506
K003239 · JJS
Bio-Rad
Chemistry · 44d
Cleared Nov 27, 2000
ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30
K003093 · CJE
Diagnostic Chemicals , Ltd.
Chemistry · 55d