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 Antigens, All Groups, Streptococcus Spp.
510(k) Number K831599
Device Name MERITEC-STREP GROUP A BETA-HEMOLYTIC
Applicant
Meridian Diagnostics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Meridian Diagnostics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.3740
Classification Product Code
GTY  
Date Received05/17/1983
Decision Date 08/11/1983
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
-
-