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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceMATRITECH NMP22(TM) TEST KIT
Applicant
ALERE SCARBOROUGH, INC
10 southgate road
scarborough, ME 04074
PMA NumberP940035
Supplement NumberS001
Date Received12/16/1996
Decision Date03/19/1997
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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.
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