• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name calibrator, multi-analyte mixture
510(k) Number K023876
Device Name VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
Original Applicant
Ortho-Clinical Diagnostics, Inc.
100 indigo creek dr.
rochester,  NY  14626 -5101
Original Contact marlene a hanna
Regulation Number862.1150
Classification Product Code
JIX  
Subsequent Product Code
JGJ  
Date Received11/21/2002
Decision Date 12/10/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-