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, All Groups, N. Meningitidis
510(k) Number K870089
Device Name IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT
Applicant
Microscan Div. Baxter Healthcare Corp.
2040 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact LORRAINE WEAVER
Correspondent
Microscan Div. Baxter Healthcare Corp.
2040 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact LORRAINE WEAVER
Regulation Number866.3390
Classification Product Code
GTJ  
Date Received01/09/1987
Decision Date 03/17/1987
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
-
-