Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Chemistry ×
13,257 results
1897–1920 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Sep 17, 2008
CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2
K082107 · JJY
Cliniqa Corporation
Chemistry · 54d
Cleared Sep 16, 2008
G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8
K071132 · LCP
Tosoh Bioscience, Inc.
Chemistry · 512d
Cleared Sep 12, 2008
ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H
K081276 · CFR
Horiba Abx
Chemistry · 130d
Cleared Sep 11, 2008
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110
K081450 · NBW
Bionime Corporation
Chemistry · 111d