AIA-PACK PA
FDA premarket approval P910065/S003 · decided 2002-09-09
Approval details
- PMA number
- P910065
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AIA-PACK PA
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Tosoh Bioscience, Inc.
- Date received
- 2002-01-09
- Decision date
- 2002-09-09
- Days to decision
- 243 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- South San Franciso, CA
- Statement
- APPROVAL TO CHANGE THE LOCATION OF THE MANUFACTURING FACILITY OF THE ASCITES FLUID USED IN THE PREPARATION OF THE MONOCLONAL ANTIBODIES FROM THE TOSOH TOKYO RESEARCH CENTER IN AYASE, JAPAN TO NISSEIKEN, CO. LTD. IN TOKYO, JAPAN.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |