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 System, Test, Vitamin D
510(k) Number K091849
Device Name IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET
Applicant
Immunodiagnostic Systems, Inc.
17029 E. Enterprise Dr.
Suite 1
Fountain Hills,  AZ  85268
Applicant Contact KEN GIBBS
Correspondent
Immunodiagnostic Systems, Inc.
17029 E. Enterprise Dr.
Suite 1
Fountain Hills,  AZ  85268
Correspondent Contact KEN GIBBS
Regulation Number862.1825
Classification Product Code
MRG  
Subsequent Product Codes
JJE   JJX  
Date Received06/22/2009
Decision Date 06/25/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-