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
1153–1176 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 30, 2013
CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST,...
K123844 · JHI
Chemtron Biotech, Inc.
Chemistry · 168d
Not Cleared May 23, 2013
TINA-QUANT HBA1C GEN. 2 TEST SYSTEM
DEN130002 · PDJ
Roche Diagnostics
Chemistry · 59d
Cleared May 21, 2013
XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)
K130189 · NTI
Luminex Molecular Diagnostics, Inc.
Chemistry · 116d
Cleared May 21, 2013
COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2
K123726 · JGS
Roche Diagnostics
Chemistry · 168d
Cleared May 21, 2013
ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK...
K123322 · CDN
Alfa Wassermann Diagnostics...
Chemistry · 207d
Cleared May 16, 2013
FORACARE GD20 BLOOD GLUCOSE MONITORING SYSTEM
K124040 · NBW
Taidoc Technology Corporation
Chemistry · 139d
Cleared May 15, 2013
VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE...
K123930 · LPS
Ortho-Clinical Diagnostics, Inc.
Chemistry · 146d
Cleared May 15, 2013
EASYRA CREATININE REAGENT
K123586 · CGX
Medica Corporation
Chemistry · 175d
Cleared May 15, 2013
ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE
K120615 · CGA
Alere San Diego Inc. Dba...
Chemistry · 441d
Cleared May 09, 2013
VARIANT(TM) II TURBO HBA1C KIT - 2.0
K130990 · LCP
Bio-Rad Laboratories, Inc., Clinical...
Chemistry · 29d
Cleared May 07, 2013
ABL90 FLEX
K123748 · CHL
Radiometer Medical Aps
Chemistry · 152d
Cleared May 06, 2013
LIQUICHEK PEDIATRIC CONTROL, LEVEL 1
K130963 · JJY
Bio-Rad Laboratories, Inc.
Chemistry · 28d
Cleared May 02, 2013
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)
K130870 · CIC
Hitachi Chemical Diagnostics, Inc.
Chemistry · 34d
Cleared May 02, 2013
ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN...
K123953 · KHS
Alfa Wassermann Diagnostic...
Chemistry · 132d
Cleared May 02, 2013
SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE...
K122525 · NBW
Biotest Medical Corp.
Chemistry · 255d
Cleared Apr 29, 2013
AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET
K130762 · JJY
Aalto Scientific, Ltd.
Chemistry · 40d
Cleared Apr 26, 2013
AUDIT MICROCV VITAMIN D LINEARITY SET
K130764 · JJX
Aalto Scientific, Ltd.
Chemistry · 37d
Cleared Apr 26, 2013
ABBOTT PHENOBARBITAL ASSAY
K123271 · DLZ
Microgenics Corp.
Chemistry · 189d
Cleared Apr 25, 2013
GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION
K130886 · NBW
Glooko, Inc.
Chemistry · 27d
Cleared Apr 25, 2013
VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM...
K130860 · LCP
Bio-Rad Laboratories, Inc., Clinical...
Chemistry · 28d
Cleared Apr 24, 2013
TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PROFESSIONAL...
K120989 · NBW
Nipro Diagnostics, Inc.
Chemistry · 387d
Cleared Apr 23, 2013
ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE...
K123018 · CFR
Alfa Wassermann Diagnostic...
Chemistry · 207d
Cleared Apr 19, 2013
MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM
K122539 · CHL
Siemens Healthcare Diagnostics
Chemistry · 241d
Cleared Apr 17, 2013
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION
K130535 · NBW
Agamatrix, Inc.
Chemistry · 47d