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
3673–3696 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 20, 2000
OLYMPUS CREATINE KINASE REAGENT OSR6179/6279
K994189 · CGS
Olympus Diagnostica GmbH
Chemistry · 38d
Cleared Jan 20, 2000
DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR
K994114 · JIS
Dade Behring, Inc.
Chemistry · 45d
Cleared Jan 20, 2000
SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL
K994005 · DJR
Syva Co.
Chemistry · 57d
Cleared Jan 20, 2000
ACON ONE STEP HOME PREGNANCY TEST STRIP
K993483 · LCX
ACON Laboratories, Inc.
Chemistry · 98d
Cleared Jan 20, 2000
ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H
K000067 · CJE
Teco Diagnostics
Chemistry · 10d
Cleared Jan 14, 2000
ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309,...
K994439 · JHX
Beckman Coulter, Inc.
Chemistry · 22d
Cleared Jan 14, 2000
ACCESS OSTASE QC
K994277 · JJX
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Jan 14, 2000
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM
K992684 · LFR
Abbott Diabetes Care, Inc.
Chemistry · 157d
Cleared Jan 13, 2000
MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC)
K993377 · NAQ
Polymer Technology Systems, Inc.
Chemistry · 107d
Cleared Jan 12, 2000
SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR
K994325 · JIS
Beckman Coulter, Inc.
Chemistry · 21d
Cleared Jan 10, 2000
CLINICAL BLOOD GAS MIXTURE
K993789 · CHL
General Air Service and Supply
Chemistry · 62d
Cleared Jan 10, 2000
ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE
K992859 · CHL
Radiometer America, Inc.
Chemistry · 138d
Cleared Jan 03, 2000
URINALYSIS REAGENT STRIPS (10 PARAMETERS)
K993850 · JMT
International Newtech Development, Inc.
Chemistry · 52d
Cleared Dec 29, 1999
HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT,...
K992148 · CGS
Morax
Chemistry · 188d
Cleared Dec 27, 1999
K-ASSAY MULTI-ANALYTE CALIBRATOR
K993853 · JIX
Kamiya Biomedical Co.
Chemistry · 45d
Cleared Dec 27, 1999
CARESIDE DIRECT BILIRUBIN
K993771 · CIG
Careside, Inc.
Chemistry · 49d
Cleared Dec 27, 1999
VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF...
K993485 · DIO
Sun Biomedical Laboratories, Inc.
Chemistry · 74d
Cleared Dec 27, 1999
MTM BIOSCANNER K TEST STRIPS, CAT # BSA610
K983860 · JMK
Polymer Technology Systems, Inc.
Chemistry · 420d
Cleared Dec 22, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS...
K994145 · JIS
Ortho-Clinical Diagnostics, Inc.
Chemistry · 14d
Cleared Dec 21, 1999
LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
K994110 · DFC
Diasorin/American Standard Companies
Chemistry · 15d
Cleared Dec 21, 1999
FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET
K993590 · LCP
Pointe Scientific, Inc.,
Chemistry · 60d
Cleared Dec 21, 1999
AXIS %CDT TURBIDIMETRIC IMMUNOASSAY
K992502 · NAO
Axis
Chemistry · 148d
Cleared Dec 21, 1999
FIRST RESPONSE 1-STEP PREGNANCY
K992232 · LCX
Armkel, LLC
Chemistry · 172d
Cleared Dec 21, 1999
QUANTECH TOTAL B-HCG ASSAY
K990258 · NAL
Quantech , Ltd.
Chemistry · 328d