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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.
 
Trade NameMATRITECH NMP22(TM) TEST KIT
Generic Namecarcinoma of urinary tract test kit
ApplicantMATRITECH, INC.
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 - other
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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