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. |
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Device | ABBOTT IMX(R) HAVAB(R)-M |
Generic Name | Hepatitis a test (antibody and igm antibody) |
Regulation Number | 866.3310 |
Applicant | Abbott Laboratories D-49C, BUILDING AP6C 100 ABBOTT PARK ROAD ABBOTT PARK NORTH, IL 60064-3500 |
PMA Number | P790019 |
Supplement Number | S009 |
Date Received | 04/23/1997 |
Decision Date | 05/28/1997 |
Reclassified Date
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02/09/2006 |
Product Code |
LOL |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Expedited Review Granted? | No |
Combination Product | No |
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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