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 culture media, antimicrobial susceptibility test, mueller hinton agar/broth
510(k) Number K850291
Device Name MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS
Applicant
REMEL CO.
12076 SANTA FE DR.
LENEXA,  KS  66215
Applicant Contact JAMES G BAXENDALE
Correspondent
REMEL CO.
12076 SANTA FE DR.
LENEXA,  KS  66215
Correspondent Contact JAMES G BAXENDALE
Regulation Number866.1700
Classification Product Code
JTZ  
Date Received01/24/1985
Decision Date 05/10/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-