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
3697–3720 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 20, 1999
PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR
K993096 · CHH
Lifestream Technologies, Inc.
Chemistry · 206d
Cleared Dec 16, 1999
AVL OPTI CRITICAL CARE ANALYZER
K993837 · CGA
Avl Scientific Corp.
Chemistry · 34d
Cleared Dec 16, 1999
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC...
K993711 · JZG
Bayer Corp.
Chemistry · 43d
Cleared Dec 16, 1999
BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12
K993571 · CDD
Bayer Corp.
Chemistry · 56d
Cleared Dec 16, 1999
WAKO L-TYPE GOT TEST
K993468 · CIT
Wako Chemicals USA, Inc.
Chemistry · 64d
Cleared Dec 16, 1999
CLEARPLAN EASY II HOME PREGNANCY TEST
K993333 · LCX
Unipath , Ltd.
Chemistry · 73d
Cleared Dec 16, 1999
FRUCTOSAMINE, MODEL FR 106-01
K991246 · LCP
A.P. Total Care, Inc.
Chemistry · 248d
Cleared Dec 09, 1999
ACCU-CHEK SIMPLICITY SYSTEM
K993829 · LFR
Roche Diagnostics Corp.
Chemistry · 27d
Cleared Dec 06, 1999
TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM)
K993353 · MMI
Bayer Corp.
Chemistry · 62d
Cleared Dec 06, 1999
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY
K993309 · MMI
Bayer Corp.
Chemistry · 63d
Cleared Dec 02, 1999
CLEARVIEW EASY HCG PREGNANCY TEST
K993703 · JHI
Unipath , Ltd.
Chemistry · 30d
Cleared Dec 02, 1999
CARESIDE ANALYZER
K993634 · JJF
Careside, Inc.
Chemistry · 36d
Cleared Dec 01, 1999
ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
K993317 · JHI
ACON Laboratories, Inc.
Chemistry · 58d
Cleared Dec 01, 1999
ACON ONE STEP PREGNANCY TEST STRIP (URINE)
K993203 · JHI
ACON Laboratories, Inc.
Chemistry · 68d
Cleared Nov 30, 1999
APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH
K993310 · JJY
Dade Behring, Inc.
Chemistry · 57d
Cleared Nov 26, 1999
K-ASSAY APO A1/B CALIBRATOR SET
K993606 · JIX
Kamiya Biomedical Co.
Chemistry · 32d
Cleared Nov 26, 1999
HICHEM ISE ELECTROLYTE BUFFER
K992844 · JGS
Elan Holdings, Inc.
Chemistry · 94d
Cleared Nov 26, 1999
HICHEM ISE ELECTROLYTE REFERENCE
K992842 · JGS
Elan Holdings, Inc.
Chemistry · 94d
Cleared Nov 26, 1999
MACRA LP(A) ENZYME IMMUNOASSAY KIT
K992665 · DFC
Trinity Biotech USA
Chemistry · 109d
Cleared Nov 24, 1999
GEM PREMIER 3000
K992834 · CHL
Instrumentation Laboratory CO
Chemistry · 93d
Cleared Nov 24, 1999
NEW MULTIPLES REAGENT STRIPS
K992257 · JIR
Bayer Corp.
Chemistry · 141d
Cleared Nov 24, 1999
ABL 735 ANALYZER
K991417 · CHL
Radiometer America, Inc.
Chemistry · 215d
Cleared Nov 23, 1999
CARDIASURE CARDIAC MARKERS CONTROL
K993723 · JJT
Quantimetrix Corp.
Chemistry · 20d
Cleared Nov 23, 1999
HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]
K993128 · CGA
Health Hero Network, Inc.
Chemistry · 64d