DR. BROWN'S HOME DRUG TESTING KIT
FDA premarket approval P950040/S003 · decided 1997-08-15
Approval details
- PMA number
- P950040
- Supplement
- S003
- Trade name
- 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
- Days to decision
- 66 days
- Decision code
- APPR
- Product code
- LDJ
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Baltimore, MD
- Statement
- 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.
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