TANDEM-MP PSA IMMUNOENZYMETRIC ASSAY
FDA premarket approval P850048/S015 · decided 1999-08-03
Approval details
- PMA number
- P850048
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TANDEM-MP PSA IMMUNOENZYMETRIC ASSAY
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Beckman Coulter, Inc.
- Date received
- 1999-07-12
- Decision date
- 1999-08-03
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- The 30-day Notice requested a change in a raw material from bovine serum to bovine serum albumin, which is used in the manufacture of a component in the Tandem(R)-MP PSA kit to improve the consistency between lots. In addition, a change in the microplate vendor to permit an additional source of microplates and to reduce manufacturing costs.
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