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 Discs, Strips And Reagents, Microorganism Differentiation
510(k) Number K941111
Device Name STREP-SURE A/E
Applicant
Clinical Standards Laboratories, Inc.
2011 E. University Dr.
Rancho Dominguez,  CA  90220
Applicant Contact JAMES R GREENWOOD, PH.D
Correspondent
Clinical Standards Laboratories, Inc.
2011 E. University Dr.
Rancho Dominguez,  CA  90220
Correspondent Contact JAMES R GREENWOOD, PH.D
Regulation Number866.2660
Classification Product Code
JTO  
Date Received03/07/1994
Decision Date 08/02/1994
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
-
-