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, Non-Selective And Non-Differential
510(k) Number K881523
Device Name DEXTROSE TRYPTONE BROTH
Applicant
Acumedia Manufacturers, Inc.
3651 Clipper Mill Rd.
Baltimore,  MD  21211
Applicant Contact CUNNINGHAM, PHD
Correspondent
Acumedia Manufacturers, Inc.
3651 Clipper Mill Rd.
Baltimore,  MD  21211
Correspondent Contact CUNNINGHAM, PHD
Regulation Number866.2300
Classification Product Code
JSG  
Date Received04/08/1988
Decision Date 04/18/1988
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
-
-