AIA-PACK PA PSA, ST AIA-PACK PA PSA
FDA premarket approval P910065/S006 · decided 2005-11-30
Approval details
- PMA number
- P910065
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AIA-PACK PA PSA, ST AIA-PACK PA PSA
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Tosoh Bioscience, Inc.
- Date received
- 2005-06-06
- Decision date
- 2005-11-30
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- South San Franciso, CA
- Statement
- APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS OF THE MONOCLONAL ANTIBODIES USED IN THE PRODUCTION OF THE ASSAYS AND CHANGE IN THE MANUFACTURING FACILITY USED FOR THE ABOVE MANUFACTURING PROCESS FROM NISSEIKEN CO., LTD., TOKYO, JAPAN TO TOSOH AIA, INC. IN TOYAMA, JAPAN.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 (K250073) | Tosoh Bioscience, Inc. | 2025-10-03 |
| ST AIA-PACK BNP Assay (K211199) | Tosoh Bioscience, Inc. | 2021-11-08 |
| Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 (K200904) | Tosoh Bioscience, Inc. | 2021-08-05 |
| ST AIA-PACK hsE2 Calibrator Set (K160113) | Tosoh Bioscience, Inc. | 2016-02-17 |
| ST AIA-PACK PROG III Calibrator Set (K153417) | Tosoh Bioscience, Inc. | 2015-12-18 |
| ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set (K150270) | Tosoh Bioscience, Inc. | 2015-10-26 |
| ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set (K143075) | Tosoh Bioscience, Inc. | 2015-07-02 |
| AIA-PACK C-Peptide Control Set (K143296) | Tosoh Bioscience, Inc. | 2014-12-16 |