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
2617–2640 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 29, 2004
DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT
K043378 · JIT
Drew Scientific , Ltd.
Chemistry · 21d
Cleared Dec 29, 2004
PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T...
K043167 · JXM
Phamatech, Inc.
Chemistry · 43d
Cleared Dec 27, 2004
MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50,...
K042362 · KHS
Diagnostic Chemicals , Ltd.
Chemistry · 118d
Cleared Dec 27, 2004
GENCHEM ELECTROLYTE BUFFER
K040977 · JGS
Genchem, Inc.
Chemistry · 257d
Cleared Dec 27, 2004
GENCHEM CREATININE REAGENT
K040976 · CGX
Genchem, Inc.
Chemistry · 257d
Cleared Dec 27, 2004
GENCHEM CO2 ACID REAGENT
K040975 · JFL
Genchem, Inc.
Chemistry · 257d
Cleared Dec 27, 2004
GLUCOSE OXIDASE, GLUCOSE
K040974 · CGA
Genchem, Inc.
Chemistry · 257d
Cleared Dec 27, 2004
BUN REAGENT
K040973 · CDS
Genchem, Inc.
Chemistry · 257d
Cleared Dec 27, 2004
CALCIUM, AZO DYE REAGENT
K040972 · CJY
Genchem, Inc.
Chemistry · 257d
Cleared Dec 23, 2004
MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY
K043318 · CGN
Roche Diagnostics Corp.
Chemistry · 21d
Cleared Dec 23, 2004
OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279
K043202 · CGS
Olympus America, Inc.
Chemistry · 35d
Not Cleared Dec 23, 2004
AMPLICHIP CYP450 TEST, MODEL 04381866190
DEN040011 · NTI
Roche Molecular Systems, Inc.
Chemistry · 3d
Cleared Dec 22, 2004
ASCENSIA ELITE DIABETES CARE SYSTEM
K043311 · NBW
Bayer Healthcare, LLC
Chemistry · 21d
Cleared Dec 22, 2004
ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM
K043158 · NBW
Bayer Healthcare, LLC
Chemistry · 37d
Cleared Dec 22, 2004
QUANTEX MYOGLOBIN
K042982 · DDR
Instrumentation Laboratory CO
Chemistry · 54d
Cleared Dec 22, 2004
GENCHEM ISE ELECTROLYTE REFERENCE
K040971 · JGS
Genchem, Inc.
Chemistry · 252d
Cleared Dec 17, 2004
MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II
K043320 · JJX
Roche Diagnostics Corp.
Chemistry · 15d
Cleared Dec 17, 2004
NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY
K042676 · DHA
Nichols Institute Diagnostics
Chemistry · 79d
Cleared Dec 17, 2004
BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116
K041619 · MMI
Biocheck, Inc.
Chemistry · 185d
Cleared Dec 09, 2004
LIQUID STABLE HBA1C CONTROL
K043070 · JJX
Canterbury Scientific , Ltd.
Chemistry · 31d
Cleared Dec 09, 2004
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23
K042838 · JIT
Ortho-Clinical Diagnostics, Inc.
Chemistry · 56d
Cleared Dec 09, 2004
NICHOLS ADVANTAGE CORTISOL
K042689 · CGR
Nichols Institute Diagnostics
Chemistry · 71d
Cleared Dec 09, 2004
AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET
K042318 · JJY
Aalto Scientific, Ltd.
Chemistry · 105d
Cleared Dec 07, 2004
TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300
K042723 · DAP
Biosite Incorporated
Chemistry · 67d