PMA P940035S001
- Device
- MATRITECH NMP22(TM) TEST KIT
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S001
- Decision date
- 1997-03-19
- Approval order 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.
Current openFDA PMA Record#
- Device
- MATRITECH NMP22(TM) TEST KIT
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S001
- Decision date
- 1997-03-19
- Decision code
- APPR
- Date received
- 1996-12-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.