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.
Approval for dr. Brown's home drug testing system. Dr. Brown's home drug testing system is an over-the-counter collection and transport system intended for use by individuals wishing to anonymously test urine samples for drugs of abuse (marijuana, cocaine, amphetamine, methamphetamine, phyencyclidine (pcp), codeine, and morphine).
| Device | DR. BROWN'S HOME DRUG TESTING KIT |
| Generic Name | Enzyme Immunoassay, Cannabinoids |
| Applicant | PERSONAL HEALTH & HYGIENE, INC. |
| Date Received | 1995-12-19 |
| Decision Date | 1997-01-21 |
| Notice Date | 1997-06-30 |
| PMA | P950040 |
| Supplement | S |
| Product Code | LDJ |
| Docket Number | 97M-0257 |
| Advisory Committee | Toxicology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PERSONAL HEALTH & HYGIENE, INC. 2 North Charles Stree baltimore, MD 21201 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P950040 | Original Filing | |
| S003 | 1997-06-10 | |
| S002 | 1997-02-05 | Normal 180 Day Track |
| S001 | 1997-01-30 | Normal 180 Day Track |