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
1201–1224 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Jan 31, 2013
LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL...
K123775 · JJY
Bio-Rad Laboratories
Chemistry · 52d