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 Antisera, All Groups, Streptococcus Spp.
510(k) Number K870854
Device Name BACTO(R) STREP GROUP KIT
Applicant
Difco Laboratories, Inc.
1180 Ellsworth Rd.
Ann Arbor,  MI  48104
Applicant Contact WALTER S FISHER
Correspondent
Difco Laboratories, Inc.
1180 Ellsworth Rd.
Ann Arbor,  MI  48104
Correspondent Contact WALTER S FISHER
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received03/03/1987
Decision Date 04/28/1987
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
-
-