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
3049–3072 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 17, 2003
TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER...
K030088 · JJY
Biosite Incorporated
Chemistry · 7d
Cleared Jan 17, 2003
CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371...
K030012 · JHX
Beckman Coulter, Inc.
Chemistry · 15d
Cleared Jan 17, 2003
GLUCOSE-SL-C ASSAY, MODEL 257-30
K023739 · CFR
Diagnostic Chemicals , Ltd.
Chemistry · 71d
Cleared Jan 16, 2003
GENZYME CONTRAST II HCG URINE/SERUM TEST
K023544 · JHI
Genzyme Corp.
Chemistry · 86d
Cleared Jan 16, 2003
MAYBE?MOM MINI OVULATION MICROSCOPE
K013582 · CEP
Maybe?Mom
Chemistry · 443d
Cleared Jan 13, 2003
RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS
K023763 · LCP
Randox Laboratories, Ltd.
Chemistry · 66d
Cleared Jan 07, 2003
ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650
K023840 · CKB
Bayer Diagnostics Corp.
Chemistry · 50d
Cleared Jan 06, 2003
VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110
K023410 · JJY
Maine Standards Co.
Chemistry · 88d
Cleared Jan 03, 2003
WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354
K023744 · JHW
Wiener Laboratories Saic
Chemistry · 57d
Cleared Jan 03, 2003
CASSETTE/URINE HCG
K023638 · LCX
Ind Diagnostic, Inc.
Chemistry · 65d
Cleared Dec 26, 2002
MODIFICATION TO ALKP
K023807 · CJE
Abbott Laboratories
Chemistry · 42d
Cleared Dec 24, 2002
RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS...
K023784 · LBR
Hemagen Diagnostics, Inc.
Chemistry · 42d
Cleared Dec 24, 2002
QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEVELS 1, 2, AND 3
K023731 · JJY
Consolidated Technology
Chemistry · 48d
Cleared Dec 23, 2002
AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)
K023396 · CIJ
Pointe Scientific, Inc.,
Chemistry · 75d
Cleared Dec 23, 2002
HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS
K023269 · DCK
Instrumentation Laboratory CO
Chemistry · 83d
Cleared Dec 20, 2002
STAT PROFILE PHOX PLUS L ANALYZER
K023567 · CHL
Nova Biomedical Corp.
Chemistry · 58d
Cleared Dec 20, 2002
ACCESS TOTAL BHCG
K023480 · JHI
Beckman Coulter, Inc.
Chemistry · 64d
Cleared Dec 19, 2002
COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
K024098 · JFY
Roche Diagnostics Corp.
Chemistry · 7d
Cleared Dec 19, 2002
MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE...
K023669 · JJY
Medical Analysis Systems, Inc.
Chemistry · 49d
Cleared Dec 19, 2002
BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117
K022660 · DRR
Biocheck, Inc.
Chemistry · 132d
Cleared Dec 17, 2002
MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3
K023867 · JJY
Medical Analysis Systems, Inc.
Chemistry · 27d
Cleared Dec 17, 2002
ST AIA-PACK TESTOSTERONE ASSAY
K023091 · CDZ
Tosoh Medics, Inc.
Chemistry · 91d
Cleared Dec 16, 2002
ABBOTT ARCHITECT FOLATE
K023397 · CGN
Abbott Laboratories
Chemistry · 68d
Cleared Dec 16, 2002
PREG-Q EARLY PREGNANCY TEST
K023027 · LCX
Yd Diagnostics
Chemistry · 96d