PMA
P950040: DR. BROWN'S HOME DRUG TESTING KIT
FDA PMA · Enzyme immunoassay, cannabinoids · Personal Health & Hygiene, Inc.
Key facts
| PMA number | P950040 |
|---|---|
| Trade name | DR. BROWN'S HOME DRUG TESTING KIT |
| Generic name | Enzyme immunoassay, cannabinoids |
| Applicant | Personal Health & Hygiene, Inc. |
| Product code | LDJ |
| Approval date | Jan 21, 1997 |
| Docket number | 97M-0257 |
| Notice date | Jun 30, 1997 |
At a glance
- 1–9 Supplements
- Aug 15, 1997 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- No Withdrawn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: