FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,234 results
1129–1152 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 31, 2013
VITROS CHEMISTRY PRODUCTS TRIG SLIDES
K130332 · CDT
Ortho-Clinical Diagnostics, Inc.
Chemistry · 109d
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