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 Antisera, Fluorescent, Herpesvirus Hominis 1,2
510(k) Number K841943
Device Name GIBCO HERPES ID KIT
Applicant
Gibco Laboratories Life Technologies, Inc.
P.O. Box 68
Grandisland,  NY  14072
Applicant Contact BRUCE H NICHOLS
Correspondent
Gibco Laboratories Life Technologies, Inc.
P.O. Box 68
Grandisland,  NY  14072
Correspondent Contact BRUCE H NICHOLS
Regulation Number866.3305
Classification Product Code
GQL  
Date Received05/11/1984
Decision Date 03/13/1985
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
-
-