COMPLEXED PSA MICROTITER ELISA
FDA premarket approval P990055/S002 · decided 2002-03-19
Approval details
- PMA number
- P990055
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- COMPLEXED PSA MICROTITER ELISA
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2001-09-20
- Decision date
- 2002-03-19
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- NAF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL TO ADD A MICROTITER PLATE CAPTURE SYSTEM TO THE CURRENT DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ONCOGENE SCIENCE COMPLEXED PSA MICROTITER ELISA AND IS INDICATED FOR THE FOLLOWING: THE ONCOGENE SCIENCE COMPLEXED PSA MICROTITER ELISA IS AN IN VITRO DIAGNOSTIC ASSAY INTENDED TO QUANTITATIVELY MEASURE COMPLEXED PSA (CPSA) IN HUMAN SERUM. THIS DEVICE IS INDICATED FOR THE MEASUREMENT OF SERUM CPSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DE
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