MATRITECH NMP22(TM) TEST KIT
FDA premarket approval P940035/S001 · decided 1997-03-19
Approval details
- PMA number
- P940035
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MATRITECH NMP22(TM) TEST KIT
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- Date received
- 1996-12-16
- Decision date
- 1997-03-19
- Days to decision
- 93 days
- Decision code
- APPR
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Scarborough, ME
- Statement
- APPROVAL FOR THE CHANGE IN SPECIMEN COLLECTION TO A SINGLE VOID OF URINE, COLLECTED BETWEEN MIDNIGHT AND NOON, WHICH WILL BE TESTED USING THE MATRITECH NMP22(R) TEST KIT.
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