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 Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
510(k) Number K971566
Device Name CREATINE KINASE-MB REAGENT SET
Applicant
Horizon Diagnostics, Inc.
3660 Plaza Dr.,Suite 4
Ann Arbor,  MI  48108
Applicant Contact DAVID L CALLENDER
Correspondent
Horizon Diagnostics, Inc.
3660 Plaza Dr.,Suite 4
Ann Arbor,  MI  48108
Correspondent Contact DAVID L CALLENDER
Regulation Number862.1215
Classification Product Code
CGS  
Date Received04/29/1997
Decision Date 07/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-