IMMULITE/IMMULITE 1000 PSA, IMMULITE 2000 PSA, IMMULITE/IMMULITE 1000 & 2000 THIRD GENERATION PSA
FDA premarket approval P930027/S013 · decided 2011-09-12
Approval details
- PMA number
- P930027
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IMMULITE/IMMULITE 1000 PSA, IMMULITE 2000 PSA, IMMULITE/IMMULITE 1000 & 2000 THIRD GENERATION PSA
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2011-08-16
- Decision date
- 2011-09-12
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Gwynedd Ll55 4el
- Statement
- PERMANENT IMPLEMENTATION OF THE INCOMING SPECIFICATION FOR ZINC CONTENT FOR 2-AMINO-2-METHYL-1- PROPANOL (AMP) BUFFER AND ELIMINATION OF SUBSTRATE VERIFICATION TESTING.
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