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
3097–3120 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 18, 2002
AMEDITECH IMMUTEST HCG PREGANCY TEST
K023126 · LCX
Ameditech, Inc.
Chemistry · 60d
Cleared Nov 15, 2002
PTS PANELS LIPID PANEL TEST STRIPS
K023558 · CHH
Polymer Technology Systems, Inc.
Chemistry · 23d
Cleared Nov 15, 2002
PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS
K023268 · JIX
Phoenix Diagnostics, Inc.
Chemistry · 46d
Cleared Nov 13, 2002
LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION
K022769 · JJX
Bionostics, Inc.
Chemistry · 84d
Cleared Nov 05, 2002
INSTANT-VIEW LH OVULATION PREDICTING TEST
K022829 · CEP
Alfa Scientific Designs, Inc.
Chemistry · 71d
Cleared Nov 05, 2002
RANDOX C-REACTIVE PROTEIN CALIBRATOR
K022682 · JIS
Randox Laboratories, Ltd.
Chemistry · 85d
Cleared Nov 01, 2002
WIENER LAB. BILIRRUBINA TOTAL AA
K022962 · CIG
Wiener Laboratories Saic
Chemistry · 56d
Cleared Nov 01, 2002
AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE)
K022681 · DHA
Azog, Inc.
Chemistry · 81d
Cleared Nov 01, 2002
AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK)
K022680 · DHA
Azog, Inc.
Chemistry · 81d
Cleared Oct 31, 2002
MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL
K023307 · JJX
Medical Analysis Systems, Inc.
Chemistry · 28d
Cleared Oct 28, 2002
MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE...
K022941 · LFR
Abbott Laboratories
Chemistry · 55d
Cleared Oct 28, 2002
ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE
K022589 · LAF
ACON Laboratories, Inc.
Chemistry · 84d
Cleared Oct 28, 2002
NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT
K021541 · JNB
Perkinelmer Life Sciences
Chemistry · 171d
Cleared Oct 24, 2002
CEDIA CYCLOSPORINE PLUS ASSAY
K023208 · MKW
Microgenics Corp.
Chemistry · 29d
Cleared Oct 24, 2002
SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM
K023194 · CGA
Lifescan, Inc.
Chemistry · 29d
Cleared Oct 24, 2002
RANDOX APOLIPOPROTEIN CALIBRATOR
K023158 · JIX
Randox Laboratories, Ltd.
Chemistry · 31d
Cleared Oct 17, 2002
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER...
K023250 · JJY
Cliniqa Corporation
Chemistry · 17d
Cleared Oct 16, 2002
CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
K023065 · MKW
Dade Behring, Inc.
Chemistry · 30d
Cleared Oct 11, 2002
SPIFE CK KIT, MODEL 3332, 3333
K022757 · JHY
Helena Laboratories
Chemistry · 52d
Cleared Oct 11, 2002
GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020
K022545 · NBW
Hypoguard USA, Inc.
Chemistry · 71d
Cleared Oct 09, 2002
BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM
K022581 · NBW
Becton, Dickinson & CO
Chemistry · 65d
Cleared Oct 09, 2002
BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM
K022580 · CGA
Becton, Dickinson & CO
Chemistry · 65d
Cleared Oct 09, 2002
PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE...
K022472 · CEW
Nichols Institute Diagnostics
Chemistry · 75d
Cleared Oct 08, 2002
LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL
K023032 · GFS
Bioresource Technology, Inc.
Chemistry · 27d