This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for labeling of your device in final printed form and for a change in the group providing phone services related to your device from joseph j. Sheerin to national medical review officers, inc.
| Device | DR. BROWN'S HOME DRUG TESTING KIT |
| Generic Name | Enzyme Immunoassay, Cannabinoids |
| Applicant | PERSONAL HEALTH & HYGIENE, INC. |
| Date Received | 1997-06-10 |
| Decision Date | 1997-08-15 |
| PMA | P950040 |
| Supplement | S003 |
| Product Code | LDJ |
| 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 |