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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePERIOCHECK TM ENZYME ACTIVITY TEST KIT
Classification Namekit, test, in vitro periodontal
Generic Namekit, test, in vitro periodontal
Applicant
ACTECH ADVANCED CLINICAL TECHNOLOGIES, INC.
117 broadway
norwood,, MA 02062
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 - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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