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
1873–1896 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 04, 2008
PRO GLUCOSE TEST STRIP
K082169 · NBW
Taidoc Technology Corporation
Chemistry · 125d
Cleared Dec 04, 2008
ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS
K080485 · CIT
Diasys Diagnostics Systems GmbH
Chemistry · 286d
Cleared Nov 26, 2008
RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01...
K081975 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 138d
Cleared Nov 19, 2008
AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5
K082714 · JJY
Aalto Scientific, Ltd.
Chemistry · 63d
Cleared Nov 17, 2008
EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT
K080823 · JFJ
Medica Corp.
Chemistry · 238d
Cleared Nov 17, 2008
CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA
K080623 · CHH
Jas Diagnostics, Inc.
Chemistry · 257d
Cleared Nov 12, 2008
DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B
K082763 · MZU
Diazyme Laboratories
Chemistry · 51d
Cleared Nov 04, 2008
ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT
K080294 · NAK
Astoria-Pacific, Inc.
Chemistry · 274d
Cleared Oct 31, 2008
IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP...
K080057 · DKZ
Novx Systems, Inc.
Chemistry · 296d
Cleared Oct 23, 2008
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS...
K081543 · JLW
Ortho-Clinical Diagnostics, Inc.
Chemistry · 143d
Cleared Oct 22, 2008
ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM
K082513 · NBW
Lifescan, Inc.
Chemistry · 50d
Cleared Oct 21, 2008
GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110
K082417 · CGA
Arkray Factory USA, Inc.
Chemistry · 60d
Cleared Oct 17, 2008
CARESENS BLOOD GLUCOSE MONITORING SYSTEM
K080923 · NBW
I-Sens, Inc.
Chemistry · 198d
Cleared Oct 17, 2008
ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT
K073309 · LCP
Horiba Abx
Chemistry · 329d
Cleared Oct 10, 2008
LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623
K082680 · JIT
Siemens Healthcare Diagnostics
Chemistry · 25d
Cleared Oct 10, 2008
A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY
K080851 · LPS
Anticancer, Inc.
Chemistry · 198d
Cleared Oct 08, 2008
GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE
K082486 · NBW
Bayer Healthcare, LLC
Chemistry · 41d
Cleared Oct 07, 2008
ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455
K082618 · NBW
Taidoc Technology Corporation
Chemistry · 28d
Cleared Oct 06, 2008
RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS
K081478 · JJX
Bionostics, Inc.
Chemistry · 132d
Cleared Sep 22, 2008
DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT...
K082645 · NBC
Siemens Healthcare Diagnostics
Chemistry · 11d
Cleared Sep 18, 2008
GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER,...
K082395 · JJX
Bionostics, Inc.
Chemistry · 30d
Cleared Sep 18, 2008
S40 CREATINE KINASE (CK)
K082226 · JHS
Alfa Wassermann Diagnostic...
Chemistry · 42d
Cleared Sep 18, 2008
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100
K081451 · NBW
Bionime Corporation
Chemistry · 118d
Cleared Sep 17, 2008
EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005
K082121 · CGA
Eps Bio Technology Corp.
Chemistry · 51d