IMMULITE 2500 AFP, MODEL L5KAP
FDA premarket approval P010007/S002 · decided 2003-12-31
Approval details
- PMA number
- P010007
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IMMULITE 2500 AFP, MODEL L5KAP
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2003-12-12
- Decision date
- 2003-12-31
- Days to decision
- 19 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- APPROVAL FOR USE OF THE IMMULITE 2000 AFT ON THE IMMULITE 2500 AUTOMATED ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IMMULITE 2500 AFP AND IS INDICATED: "FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE 2500 ANALYZERS FOR THE QUANTITATIVE MEASUREMENT OF ALPHA-FETOPROTEIN (AFP) IN EITHER OF TWO CONTEXTS: (1) SERIAL MEASUREMENTS IN HUMAN SERUM TO AID IN THE MANAGEMENT OF PATIENTS WITH NONSEMINOMATOUS TESTICULAR CANCER; OR (2) MEASUREMENTS IN MATERNAL SERUM AND AMNIOTIC FL
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