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 | AIA PACK PA |
Generic Name | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
Regulation Number | 866.6010 |
Applicant | TOSOH BIOSCIENCE, INC. 6000 SHORELINE COURT SUITE 101 SOUTH SAN FRANCISCO, CA 94080 |
PMA Number | P910065 |
Supplement Number | S002 |
Date Received | 12/16/1999 |
Decision Date | 03/03/2000 |
Product Code |
LTJ |
Advisory Committee |
Immunology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of the AIA 600 II analyzer instrument to the list of approved analyzers using the AIA-Pack PA assay. |
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