Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• 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
• Date Received: 10/02/1987
• Decision Date: 08/14/1990
• Product Code: MCL
• Docket Number: 90M-0327
• Notice Date: 11/23/1990
• Advisory Committee: Clinical Chemistry
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Supplements: S001