Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Test, Urea (Breath Or Blood)
510(k) Number K092817
Device Name POC-AS10 AUTO SAMPLER
Applicant
Otsuka Pharmaceutical Co., Ltd.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact CYNTHIA A SINCLAIR
Correspondent
Otsuka Pharmaceutical Co., Ltd.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact CYNTHIA A SINCLAIR
Regulation Number866.3110
Classification Product Code
MSQ  
Subsequent Product Code
JJQ  
Date Received09/14/2009
Decision Date 03/09/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-