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 Cytokeratins
510(k) Number K881259
Device Name MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL
Applicant
Triton Biosciences, Inc.
1501 Harbor Bay Pkwy.
Alameda,  CA  94501
Applicant Contact BARBARA L WESTRICK
Correspondent
Triton Biosciences, Inc.
1501 Harbor Bay Pkwy.
Alameda,  CA  94501
Correspondent Contact BARBARA L WESTRICK
Regulation Number866.5550
Classification Product Code
LYE  
Date Received03/23/1988
Decision Date 10/12/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-