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 Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K883012
Device Name A.QC CHEMISTRY CONTROL LEVEL 2
Applicant
Arden Medical Systems, Inc.
2675 Long Lake Rd.
P.O. Box 64302
Roseville,  MN  55113
Applicant Contact BARBARA E ROTH
Correspondent
Arden Medical Systems, Inc.
2675 Long Lake Rd.
P.O. Box 64302
Roseville,  MN  55113
Correspondent Contact BARBARA E ROTH
Regulation Number862.1660
Classification Product Code
JJY  
Date Received07/19/1988
Decision Date 09/09/1988
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
-
-