ABBOTT IMX AFP ASSAY
FDA premarket approval P820060/S014 · decided 2002-09-05
Approval details
- PMA number
- P820060
- Supplement
- S014
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Other
- Trade name
- ABBOTT IMX AFP ASSAY
- Generic name
- KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
- Applicant
- Abbott Laboratories
- Date received
- 2001-09-28
- Decision date
- 2002-09-05
- Days to decision
- 342 days
- Decision code
- APPR
- Product code
- LOJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL TO ADD A QUALITY CONTROL TEST WHICH WILL BE PERFORMED AFTER THE REAGENT PACK IS PACKAGED.
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