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 Powders, Antimicrobial
510(k) Number K872081
Device Name CIPRO (TM) DIAGNOSTIC POWDER
Applicant
Miles Pharmaceuticals
400 Morgan Ln.
West Haven,  CT  06516
Applicant Contact CHARLES F RAYNER
Correspondent
Miles Pharmaceuticals
400 Morgan Ln.
West Haven,  CT  06516
Correspondent Contact CHARLES F RAYNER
Regulation Number866.1640
Classification Product Code
JTT  
Date Received05/29/1987
Decision Date 06/15/1987
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
-
-