AFP CONTROL PACK
FDA premarket approval P820060/S017 · decided 2003-03-05
Approval details
- PMA number
- P820060
- Supplement
- S017
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AFP CONTROL PACK
- Generic name
- KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
- Applicant
- Abbott Laboratories
- Date received
- 2003-01-30
- Decision date
- 2003-03-05
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- LOJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR INITIATING HEAT STRESS REFERENCE TESTING FOR THE PLASMA DIAGNOSTIC BASE (PDB; CONTROL DILUENT) USED IN THE PREPARATION OF THE CONTROLS FOR THE AFP ASSAYS.
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