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 Antistreptolysin - Titer/Streptolysin O Reagent
510(k) Number K901371
Device Name ASO-CUBE(TM)
Applicant
Difco Laboratories, Inc.
P. O. Box 331058
Detroit,  MI  48232 -7058
Applicant Contact WALTER S FISHER
Correspondent
Difco Laboratories, Inc.
P. O. Box 331058
Detroit,  MI  48232 -7058
Correspondent Contact WALTER S FISHER
Regulation Number866.3720
Classification Product Code
GTQ  
Date Received03/23/1990
Decision Date 05/15/1990
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
-
-