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 Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
510(k) Number K914022
Device Name SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS
Applicant
Pharmacia Diagnostics, Inc.
9033 Red Branch Rd.
Columbia,  MD  21045
Applicant Contact JUDITH SMITH
Correspondent
Pharmacia Diagnostics, Inc.
9033 Red Branch Rd.
Columbia,  MD  21045
Correspondent Contact JUDITH SMITH
Regulation Number866.3900
Classification Product Code
LFY  
Date Received09/09/1991
Decision Date 01/27/1992
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
-
-