PERIOCHECK TM ENZYME ACTIVITY TEST KIT

FDA Premarket Approval P870059 S001

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.

Pre-market Approval Supplement Details

• Device: PERIOCHECK TM ENZYME ACTIVITY TEST KIT
• Generic Name: Kit, Test, In Vitro Periodontal
• Applicant: ACTECH ADVANCED CLINICAL TECHNOLOGIES, INC.
• Date Received: 1991-09-06
• Decision Date: 1991-10-16
• PMA: P870059
• Supplement: S001
• Product Code: MCL
• Advisory Committee: Clinical Chemistry
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: ACTECH ADVANCED CLINICAL TECHNOLOGIES, INC. 117 Broadway norwood,, MA 02062

Supplemental Filings

Supplement Number	Date	Supplement Type
P870059		Original Filing
S001	1991-09-06	Normal 180 Day Track