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 Calibrator, Surrogate
510(k) Number K882220
Device Name CALIBRATION KIT
Applicant
King Diagnostics, Inc.
6856 Hawthorn Park Dr.
Indianapolis,  IN  46220
Applicant Contact FRANCES K LOH
Correspondent
King Diagnostics, Inc.
6856 Hawthorn Park Dr.
Indianapolis,  IN  46220
Correspondent Contact FRANCES K LOH
Regulation Number862.1150
Classification Product Code
JIW  
Date Received05/26/1988
Decision Date 08/02/1988
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
-
-