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 Kit, Identification, Yeast
510(k) Number K943621
Device Name RAPID YEAST PLUS SYSTEM
Applicant
Innovative Diagnostic Systems, Inc.
3404 Oakcliff Rd. #C-1
Atlanta,  GA  30340
Applicant Contact LOUIS A ERIQUEZ, PH.D.
Correspondent
Innovative Diagnostic Systems, Inc.
3404 Oakcliff Rd. #C-1
Atlanta,  GA  30340
Correspondent Contact LOUIS A ERIQUEZ, PH.D.
Regulation Number866.2660
Classification Product Code
JXB  
Date Received07/27/1994
Decision Date 01/27/1995
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
Recalls CDRH Recalls
-
-