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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.
 
DeviceABBOTT IMX(R) HAVAB(R)-M
Generic NameHepatitis a test (antibody and igm antibody)
Regulation Number866.3310
ApplicantAbbott Laboratories
D-49c, Bldg. Ap6c
100 Abbott Park Rd.
Abbott Park North, IL 60064
PMA NumberP790019
Supplement NumberS009
Date Received04/23/1997
Decision Date05/28/1997
Reclassified Date02/09/2006
Product Code LOL 
Advisory Committee Microbiology
Supplement TypeSpecial (Immediate Track)
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE SPECIFICATIONS FOR THE POSITIVE CONTROL SAMPLE TO STANDARD RATIO FROM 0.90-1.15 TO 0.85-1.15, AND A CHANGE IN THE EVALUATION OF THE HEPATITIS A VIRUS SOLUTION AND THE HAVAB(R)-M EIA CONJUGATE FROM A SAMPLE TO STANDARD RATIO TO A SAMPLE TO TARGET RATIO.
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