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 Photometric Method, Magnesium
510(k) Number K930074
Device Name IN-VITRO DIAGNOSTIC REAGENT SET
Applicant
Horizon Diagnostics, Inc.
2195 Spring Arbor Rd.
Jackson,  MI  49203
Applicant Contact DAVID K GARCIA
Correspondent
Horizon Diagnostics, Inc.
2195 Spring Arbor Rd.
Jackson,  MI  49203
Correspondent Contact DAVID K GARCIA
Regulation Number862.1495
Classification Product Code
JGJ  
Date Received01/07/1993
Decision Date 05/11/1993
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
-
-