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 susceptibility test discs, antimicrobial
510(k) Number K964489
Device Name CEFACLOR ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
Applicant
UNIPATH LTD.
15 OAK ST.
BEVERLY FARMS,  MA  01915
Applicant Contact FRAN WHITE
Correspondent
UNIPATH LTD.
15 OAK ST.
BEVERLY FARMS,  MA  01915
Correspondent Contact FRAN WHITE
Regulation Number866.1620
Classification Product Code
JTN  
Date Received11/08/1996
Decision Date 02/07/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-