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: changing the testing laboratory to americal medical laboratory (aml); including heroin testing as part of the test system; and revised labeling in association with the added heroin testing.
| Device | DR. BROWN'S HOME DRUG TESTING KIT |
| Generic Name | Enzyme Immunoassay, Cannabinoids |
| Applicant | PERSONAL HEALTH & HYGIENE, INC. |
| Date Received | 1997-02-05 |
| Decision Date | 1997-02-05 |
| PMA | P950040 |
| Supplement | S002 |
| Product Code | LDJ |
| Advisory Committee | Toxicology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |