DR. BROWN'S HOME DRUG TESTING KIT
FDA premarket approval P950040/S002 · decided 1997-02-05
Approval details
- PMA number
- P950040
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 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
- Days to decision
- 0 days
- Decision code
- APPR
- Product code
- LDJ
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Baltimore, MD
- 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.
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