NMP22 BLADDERCHEK TEST KIT
FDA premarket approval P940035/S006 · decided 2011-11-15
Approval details
- PMA number
- P940035
- Supplement
- S006
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NMP22 BLADDERCHEK TEST KIT
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- Date received
- 2011-05-11
- Decision date
- 2011-11-15
- Days to decision
- 188 days
- Decision code
- APPR
- Product code
- NAH
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Scarborough, ME
- Statement
- APPROVAL FOR MANUFACTURING SITE LOCATED AT ALERE SCARBOROUGH, INC. IN SCARBOROUGH, MAINE.
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