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 Device, Specimen Collection
510(k) Number K924331
Device Name TRANSYSTEM LIQUID STUART MEDIUM
Applicant
Pro-Lab Diagnostics
20 Mural St.
Richmond Hill
Ontario,  CA
Applicant Contact ROBERT RAE
Correspondent
Pro-Lab Diagnostics
20 Mural St.
Richmond Hill
Ontario,  CA
Correspondent Contact ROBERT RAE
Regulation Number866.2900
Classification Product Code
LIO  
Date Received08/27/1992
Decision Date 12/24/1992
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
-
-