Access Hybritech Free PSA Reagents on the Access Immunoassay Systems
FDA premarket approval P970038/S034 · decided 2017-07-07
Approval details
- PMA number
- P970038
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Access Hybritech Free PSA Reagents on the Access Immunoassay Systems
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2017-06-09
- Decision date
- 2017-07-07
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- Manufacturing change to update a specification to allow for a limited amount of flash local to the gate location (where plastic material is injected into the reaction vessel) for the Access 2 Reaction Vessels, which are used during the processing of the assays.
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