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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 NamePERIOCHECK TM ENZYME ACTIVITY TEST KIT
Classification Namekit, test, in vitro periodontal
Generic Namedental enzyme test kit
ApplicantACTECH ADVANCED CLINICAL TECHNOLOGIES, INC.
PMA NumberP870059
Supplement NumberS001
Date Received09/06/1991
Decision Date10/16/1991
Product Code
MCL
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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