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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.
 
DeviceETI-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 NumberS012
Date Received11/14/2005
Decision Date12/12/2005
Reclassified Date02/09/2006
Product Code LOL 
Advisory Committee Microbiology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGE IN THE MANUFACTURING PROCESS FOR THE NEUTRALIZING SOLUTION (HAV REAGENT).
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