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 | HYBRITECH(R) TANDEM (R) PSA ASSAY IMMUNOMETRIC |
Generic Name | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
Regulation Number | 866.6010 |
Applicant | BECKMAN COULTER, INC. 250 SOUTH KRAEMER BLVD M/S W-110 BREA, CA 92822 |
PMA Number | P850048 |
Supplement Number | S009 |
Date Received | 06/29/1992 |
Decision Date | 08/25/1994 |
Product Code |
LTJ |
Docket Number | 94M-0327 |
Notice Date | 10/14/1994 |
Advisory Committee |
Immunology |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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