RAPID FFN FOR THE TLIIQ SYSTEM
FDA premarket approval P920048/S011 · decided 2016-02-05
Approval details
- PMA number
- P920048
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RAPID FFN FOR THE TLIIQ SYSTEM
- Generic name
- ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
- Applicant
- Hologic, Inc.
- Date received
- 2015-06-10
- Decision date
- 2016-02-05
- Days to decision
- 240 days
- Decision code
- APPR
- Product code
- LKV
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Sunnyvale, CA
- Statement
- Approval for design modifications to the cassette inner housing of your Rapid fFN test, to the pneumatic press plate used in the automated manufacturing process, and for introduction of a thickness gauge in the automated manufacturing process.
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