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
2569–2592 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 26, 2005
QUANTIA LA(A)
K050487 · DFC
Biokit, S.A.
Chemistry · 60d
Cleared Apr 25, 2005
PROOF POSITIVE ELECTRONIC PREGNANCY TEST
K043231 · LCX
Mizuho USA, Inc.
Chemistry · 154d
Cleared Apr 22, 2005
OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE)
K050423 · CHL
Roche Diagnostics
Chemistry · 63d
Cleared Apr 22, 2005
ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS
K043228 · NBC
Bayer Healthcare, LLC
Chemistry · 151d
Cleared Apr 22, 2005
SAFEPICO
K043143 · JKA
Radiometer Medical Aps
Chemistry · 158d
Cleared Apr 21, 2005
MICROALBUMIN TIA REAGENT
K050576 · DDZ
Good Biotech Corp.
Chemistry · 45d
Cleared Apr 20, 2005
URISCAN OPTIMA II URINE ANALYZER
K050801 · JIL
Yd Diagnostics
Chemistry · 21d
Cleared Apr 15, 2005
VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES
K042927 · PJE
Greiner Bio-One Vacuette North America
Chemistry · 175d
Cleared Apr 12, 2005
OSOM HCG COMBO TEST
K043385 · JHI
Genzyme Diagnostics
Chemistry · 124d
Cleared Apr 08, 2005
BLOOD GLUCOSE MONITORING SYSTEM
K043543 · NBW
American Healthcare, Inc.
Chemistry · 109d
Cleared Apr 08, 2005
EASYGLUCO IGM-0002 G2
K043512 · CGA
American Healthcare, Inc.
Chemistry · 109d
Cleared Apr 08, 2005
ONE STEP HCG URINE PREGNANCY TEST
K043443 · LCX
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 115d
Cleared Apr 06, 2005
MODIFICATION TO BVBLUE
K050755 · MXB
Gryphus Diagnostics, LLC
Chemistry · 14d
Cleared Apr 06, 2005
SPOTCHEM II CREATININE, AMYLASE & ALP TESTS
K050652 · CGX
Arkray, Inc.
Chemistry · 23d
Cleared Mar 29, 2005
PREGNANCY-SKREEN
K050328 · JJX
Biochemical Diagnostic, Inc.
Chemistry · 48d
Cleared Mar 28, 2005
SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT
K043556 · JXM
Beckman Coulter, Inc.
Chemistry · 91d
Cleared Mar 25, 2005
VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS
K050504 · JJY
Maine Standards Co.
Chemistry · 25d
Cleared Mar 25, 2005
ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100
K041881 · CGA
Hypoguard USA, Inc.
Chemistry · 256d
Cleared Mar 24, 2005
QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL
K050536 · JJY
Bio-Rad
Chemistry · 22d
Cleared Mar 22, 2005
TRIAGE TOX DRUG SCREEN CONTROLS
K050037 · DIF
Biosite Incorporated
Chemistry · 74d
Cleared Mar 14, 2005
STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER
K042169 · JJE
Stanbio Laboratory
Chemistry · 215d
Cleared Mar 07, 2005
CLEVER CHEK TD-3213
K042795 · NBW
Taidoc Technology Corporation
Chemistry · 151d
Cleared Mar 04, 2005
MODIFICATION TO: INSTAREAD LITHIUM SYSTEM
K050338 · JIH
Akers Biosciences, Inc.
Chemistry · 21d
Cleared Feb 25, 2005
RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER
K050100 · JJX
Bionostics, Inc.
Chemistry · 38d