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 Supplement, Culture Media
510(k) Number K861791
Device Name PENICILLIN-STREPTOMYCIN-FUNGIZONE
Applicant
Flow Laboratories, Inc.
7655 Old Springhouse Rd.
Mclean,  VA  22102
Applicant Contact BISHOP, PH.D.
Correspondent
Flow Laboratories, Inc.
7655 Old Springhouse Rd.
Mclean,  VA  22102
Correspondent Contact BISHOP, PH.D.
Regulation Number866.2450
Classification Product Code
JSK  
Date Received05/09/1986
Decision Date 05/20/1986
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
-
-