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. |
| Date Received | 1987-10-02 |
| Decision Date | 1990-08-14 |
| Notice Date | 1990-11-23 |
| PMA | P870059 |
| Supplement | S |
| Product Code | MCL |
| Docket Number | 90M-0327 |
| Advisory Committee | Clinical Chemistry |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ACTECH ADVANCED CLINICAL TECHNOLOGIES, INC. 117 Broadway norwood,, MA 02062 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P870059 | Original Filing | |
| S001 | 1991-09-06 | Normal 180 Day Track |