|
Device | DR. BROWN'S HOME DRUG TESTING KIT |
Generic Name | Enzyme immunoassay, cannabinoids |
Regulation Number | 862.3870 |
Applicant | PERSONAL HEALTH & HYGIENE, INC. 2 NORTH CHARLES STREE BALTIMORE, MD 21201 |
PMA Number | P950040 |
Supplement Number | S002 |
Date Received | 02/05/1997 |
Decision Date | 02/05/1997 |
Product Code |
LDJ |
Advisory Committee |
Toxicology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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. |