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 K924766
Device Name REMEL OFLOXACIN 5MCG SUSCEPTIBILITY DISK
Applicant
Remel Co.
12076 Santa Fe Dr.
Lenexa,  KS  66215
Applicant Contact ROBERT W FEIRING
Correspondent
Remel Co.
12076 Santa Fe Dr.
Lenexa,  KS  66215
Correspondent Contact ROBERT W FEIRING
Regulation Number866.1620
Classification Product Code
JTN  
Date Received09/23/1992
Decision Date 10/26/1992
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
-
-