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. |
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Device | PERIOCHECK TM ENZYME ACTIVITY TEST KIT |
Generic Name | KIT, TEST, IN VITRO PERIODONTAL |
Applicant | ACTECH ADVANCED CLINICAL TECHNOLOGIES, INC. 117 BROADWAY NORWOOD,, MA 02062 |
PMA Number | P870059 |
Supplement Number | S001 |
Date Received | 09/06/1991 |
Decision Date | 10/16/1991 |
Product Code |
MCL |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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