PMA
P870059: PERIOCHECK TM ENZYME ACTIVITY TEST KIT
FDA PMA · KIT, TEST, IN VITRO PERIODONTAL · Actech Advanced Clinical Technologies, Inc.
Key facts
| PMA number | P870059 |
|---|---|
| Trade name | PERIOCHECK TM ENZYME ACTIVITY TEST KIT |
| Generic name | KIT, TEST, IN VITRO PERIODONTAL |
| Applicant | Actech Advanced Clinical Technologies, Inc. |
| Product code | MCL |
| Approval date | Aug 14, 1990 |
| Docket number | 90M-0327 |
| Notice date | Nov 23, 1990 |
At a glance
- 1–9 Supplements
- Oct 16, 1991 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: