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 Culture Media, Propagating Transport
510(k) Number K896296
Device Name INPOUCH-TV POUCH
Applicant
Biomed Diagnostics, Inc.
810 Menkar Ave.
San Jose,  CA  95128
Applicant Contact BECKER, PHD
Correspondent
Biomed Diagnostics, Inc.
810 Menkar Ave.
San Jose,  CA  95128
Correspondent Contact BECKER, PHD
Regulation Number866.2390
Classification Product Code
JSN  
Date Received10/31/1989
Decision Date 01/29/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-