FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
PMA: P010007
·
Supplement: S013
·
Decision Sep 8, 2020
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
- Trade Name
- IMMULITE, IMMULITE 1000, IMMULITE 2000, and IMMULITE 2500 AFP
- PMA Number
- P010007
- Supplement Number
- S013
- Device Class
- FDA Class 3
- Product Code
- LOK
- Generic Name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Medical Specialty
- Unknown
- Advisory Committee
- Immunology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- September 8, 2020
- Date Received
- August 12, 2020
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Remove select inspection criteria from the raw materials used to manufacture IMMULITE Substrate Reagent.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LOK | Kit, Test, Alpha-Fetoprotein For Neural Tube Defects | FDA class 3 | Unknown |