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 Catalytic Methods, Amylase
510(k) Number K930678
Device Name AMYLASE
Applicant
Horizon Diagnostics, Inc.
3660 Plaza Dr.,Suite 4
Ann Arbor,  MI  48108
Applicant Contact HARRY KLENNER
Correspondent
Horizon Diagnostics, Inc.
3660 Plaza Dr.,Suite 4
Ann Arbor,  MI  48108
Correspondent Contact HARRY KLENNER
Regulation Number862.1070
Classification Product Code
JFJ  
Date Received02/09/1993
Decision Date 04/06/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-