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 Immunoassay, Carbamazepine
510(k) Number K850807
Device Name COBAS FP REAGENTS FOR CARBAMAZEPINE
Applicant
Roche Diagnostic Systems, Inc.
11 Franklin Ave.
Belleville,  NJ  07109
Applicant Contact DONALD KAFADER
Correspondent
Roche Diagnostic Systems, Inc.
11 Franklin Ave.
Belleville,  NJ  07109
Correspondent Contact DONALD KAFADER
Regulation Number862.3645
Classification Product Code
KLT  
Date Received02/27/1985
Decision Date 03/22/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-