ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM
FDA premarket approval P970038/S015 · decided 2012-02-17
Approval details
- PMA number
- P970038
- Supplement
- S015
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2011-12-23
- Decision date
- 2012-02-17
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- APPROVAL FOR THE CHANGE IN POLYPROPYLENE RESIN USED FOR MANUFACTURING OF THE REAGENT PACK CONTAINER.
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510(k) clearances by this applicant
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|---|---|---|
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