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
1177–1200 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 11, 2013
PICCOLO LACTATE TEST SYSTEM
K130113 · KHP
Abaxis, Inc.
Chemistry · 54d
Cleared Mar 08, 2013
FASTPACK CONTROL KIT
K123725 · JJY
Qualigen, Inc.
Chemistry · 94d
Cleared Mar 08, 2013
BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)
K113636 · CGA
Philosys Co., Ltd.
Chemistry · 455d
Cleared Mar 07, 2013
DIMENSION VISTA
K123677 · JIF
Siemens Healthcare Diagnostics
Chemistry · 97d
Cleared Mar 07, 2013
GENESIS HEALTH RECORD SYSTEM, (GHRS)
K123136 · NBW
Genesis Health Technologies
Chemistry · 153d
Cleared Mar 01, 2013
LIQUID ASSAYED MULTIQUAL PREMIUM
K130162 · JJY
Bio-Rad Laboratories
Chemistry · 37d
Cleared Mar 01, 2013
EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT
K123802 · CIG
Medica Corp.
Chemistry · 81d
Cleared Feb 28, 2013
COBAS INTEGRA BILIRUBIN DIRECT GEN.2
K123965 · CIG
Roche Diagnostics
Chemistry · 64d
Cleared Feb 15, 2013
PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM
K130200 · CHH
Abaxis, Inc.
Chemistry · 18d
Cleared Feb 15, 2013
DIMENSION CHEMISTRY III CALIBRATORY
K123321 · JIX
Siemens Healthcare Diagnostics
Chemistry · 112d
Cleared Feb 15, 2013
DIMENSION AMMONIA FLEX REAGENT CARTRIDGE
K123320 · JIF
Siemens Healthcare Diagnostics
Chemistry · 112d
Cleared Feb 15, 2013
ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH...
K122177 · JIT
Elitechgroup
Chemistry · 207d
Cleared Feb 15, 2013
VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN...
K121608 · MRG
Ortho-Clinical Diagnostics, Inc.
Chemistry · 259d
Cleared Feb 14, 2013
GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK
K123851 · JJX
Bionostics, Inc.
Chemistry · 62d
Cleared Feb 14, 2013
GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT...
K121433 · LFR
Hmd Biomedical, Inc.
Chemistry · 276d
Cleared Feb 12, 2013
ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
K113614 · NBW
Roche Diagnostics
Chemistry · 434d
Cleared Feb 11, 2013
LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM
K102751 · NBW
Ceragem Medisys, Inc.
Chemistry · 872d
Cleared Feb 08, 2013
ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET,...
K123131 · MRG
Tosoh Bioscience, Inc.
Chemistry · 127d
Cleared Feb 07, 2013
TOXCUP DRUG SCREEN CUP
K122633 · LDJ
Branan Medical Corp.
Chemistry · 162d
Cleared Feb 07, 2013
ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM
K120708 · NBW
Cilag GmbH International
Chemistry · 336d
Cleared Feb 07, 2013
ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION
K120558 · NBW
Lifescan, Inc.
Chemistry · 349d
Cleared Feb 05, 2013
EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I...
K123050 · LCX
Nantong Biotechnology Co., Ltd.
Chemistry · 130d
Cleared Feb 01, 2013
ARCHITECT TOTAL BILIRUBIN
K121985 · CIG
Abbott Laboratories
Chemistry · 210d
Cleared Feb 01, 2013
AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM
K121456 · KQO
Arkray, Inc.
Chemistry · 261d