ALERE NMP22 TEST
FDA premarket approval P940035/S010 · decided 2013-07-16
Approval details
- PMA number
- P940035
- Supplement
- S010
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ALERE NMP22 TEST
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- Date received
- 2013-07-10
- Decision date
- 2013-07-16
- Days to decision
- 6 days
- Decision code
- APPR
- Product code
- NAH
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Scarborough, ME
- Statement
- APPROVAL FOR ADDITIONS TO THE LIMITATIONS AND PRECAUTIONS SECTIONS OF THE PACKAGE INSERT.
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