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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDIASORIN ETI-AB-HAVK PLUS
Generic NameHepatitis a test (antibody and igm antibody)
Regulation Number866.3310
ApplicantDiasorin
1951 Northwestern Ave.
P.O. Box 285
Stillwater, MN 55082
PMA NumberP890019
Supplement NumberS007
Date Received10/17/2002
Decision Date11/08/2002
Reclassified Date02/09/2006
Product Code LOL 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN THE VENDOR OF THE BULK SOLUTION USED IN THE PREPARATION OF THE CHROMAGEN/SUBSTRATE KIT REAGENT WITH AN ACCOMPANYING CHANGE IN THE STOP SOLUTION CONCENTRATION.
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