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 | ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT |
Generic Name | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
Applicant | BECKMAN COULTER, INC. 250 SOUTH KRAEMER BLVD M/S W-110 BREA, CA 92822 |
PMA Number | P970038 |
Supplement Number | S004 |
Date Received | 08/27/1999 |
Decision Date | 02/24/2000 |
Product Code |
MTG |
Advisory Committee |
Immunology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Supplemental approval for the addition of the Access Hybritech free PSA assay on the Access Immunoassay analyzer to the other approved instrument platforms. |
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