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 Prealbumin, Antigen, Antiserum, Control
510(k) Number K972638
Device Name TINA-QUANT PREALBUMIN
Applicant
Boehringer Mannheim Corp.
2380a Bisso Ln.
Concord,  CA  94520
Applicant Contact MARY KONING
Correspondent
Boehringer Mannheim Corp.
2380a Bisso Ln.
Concord,  CA  94520
Correspondent Contact MARY KONING
Regulation Number866.5060
Classification Product Code
JZJ  
Date Received07/15/1997
Decision Date 01/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-