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
5953–5976 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 26, 1993
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI)
K924488 · JIH
Eastman Kodak Company
Chemistry · 145d
Cleared Jan 26, 1993
TRIGLYCERIDES
K924710 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 130d
Cleared Jan 26, 1993
ABBOTT IMX T4
K925110 · CDX
Abbott Laboratories
Chemistry · 109d
Cleared Jan 26, 1993
OLYMPUS URIC ACID REAGENT
K925113 · KNK
Olympus Corp.
Chemistry · 109d
Cleared Jan 26, 1993
OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT
K925155 · CIT
Olympus Corp.
Chemistry · 105d
Cleared Jan 26, 1993
OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT
K925337 · JQB
Olympus Corp.
Chemistry · 98d
Cleared Jan 26, 1993
REFRACTROL-SP
K926095 · JJX
Medical Specialties, Inc.
Chemistry · 55d
Cleared Jan 26, 1993
LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST
K926308 · LCX
Princeton Biomedix
Chemistry · 42d
Cleared Jan 21, 1993
MICROPROTEIN REAGENT SET
K921412 · CEK
Sterling Diagnostics, Inc.
Chemistry · 303d
Cleared Jan 13, 1993
HDL-CHOLESTEROL STANDARD, MODIFICATION
K924904 · JIS
Verichem Laboratories, Inc.
Chemistry · 106d
Cleared Jan 13, 1993
PRO-STEP HCG
K925125 · JHI
Disease Detection International, Inc.
Chemistry · 92d
Cleared Jan 13, 1993
IMX PAP
K925377 · JFH
Abbott Laboratories
Chemistry · 82d
Cleared Jan 13, 1993
ACCESS DIGOXIN ASSAY
K925802 · KXT
Bio-Rad Laboratories, Inc.
Chemistry · 58d
Cleared Jan 11, 1993
DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD
K924493 · JJX
Casco Standards
Chemistry · 136d
Cleared Jan 11, 1993
ASIA-PACK TSH CALIBRATION VERIFICATION TEST SET
K924852 · JJX
Tosoh Medics, Inc.
Chemistry · 105d
Cleared Jan 11, 1993
AIA-PACK PRL CALIBRATION VERIFICATION TEST SET
K924856 · JJX
Tosoh Medics, Inc.
Chemistry · 105d
Cleared Jan 06, 1993
DIRECT LDL CHOLES IMMUNOSEPARATION REAGENT
K924674 · MRR
Genzyme Corp.
Chemistry · 112d
Cleared Jan 06, 1993
PREGNAGEN 1-STEP PREGNANCY TEST
K925189 · LCX
Biogenex Laboratories
Chemistry · 85d
Cleared Jan 06, 1993
ACTIVE RENIN IMMUNORADIOMETRIC ASSAY
K925998 · CIB
Nichols Institute Diagnostics
Chemistry · 40d
Cleared Jan 05, 1993
DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III
K926046 · JJY
Baxter Diagnostics, Inc.
Chemistry · 35d
Cleared Jan 04, 1993
ROCHE REAGENT FOR AST
K924244 · CIT
Roche Diagnostic Systems, Inc.
Chemistry · 133d
Cleared Jan 04, 1993
OLYMPUS CREATINE KINASE REAGENT
K924832 · CGS
Olympus Corp.
Chemistry · 101d
Cleared Jan 04, 1993
UREA NITROGEN TEST
K925002 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 94d
Cleared Jan 04, 1993
ABBOTT TDX/TDXFLX TT4
K925109 · CDX
Abbott Laboratories
Chemistry · 87d