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Device | ELECSYS TOTAL PSA TEST SYSTEM ON COBAS E 601 IMMUNOASSAY ANALYZER |
Generic Name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 |
PMA Number | P990056 |
Supplement Number | S008 |
Date Received | 03/28/2008 |
Decision Date | 10/17/2008 |
Product Code |
MTF |
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 APPROVAL FOR EXTENSION OF THE ELECSYS TOTAL PSA SYSTEM ONTO UPDATED MODEL OF THE MODULAR ANALYTICS E170 ANALYZER, KNOWN AS THE COBAS E 601 ANALYZER. |