NMP22 BLADDERCHEK TEST
FDA premarket approval P940035/S009 · decided 2013-04-02
Approval details
- PMA number
- P940035
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NMP22 BLADDERCHEK TEST
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- Date received
- 2013-03-18
- Decision date
- 2013-04-02
- Days to decision
- 15 days
- Decision code
- OK30
- Product code
- NAH
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Scarborough, ME
- Statement
- INCREASE THE MANUFACTURING EFFICIENCY OF THE ASSEMBLED CASSETTE BY MODIFYING THE ASSEMBLY METHOD USED IN THE MANUFACTURE OF NMP22 BLADDERCHEK FROM ASSEMBLED AND POUCHED MANUALLY BY HAND BY OPERATORS, TO BE ASSEMBLED BY VALIDATED AUTOMATED EQUIPMENT.
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