DR. BROWN'S HOME DRUG TESTING KIT
FDA premarket approval P950040 · decided 1997-01-21
Approval details
- PMA number
- P950040
- Trade name
- DR. BROWN'S HOME DRUG TESTING KIT
- Generic name
- Enzyme immunoassay, cannabinoids
- Applicant
- Personal Health & Hygiene, Inc.
- Date received
- 1995-12-19
- Decision date
- 1997-01-21
- Days to decision
- 399 days
- Decision code
- APPR
- Product code
- LDJ
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Baltimore, MD
- Statement
- APPROVAL FOR DR. BROWN'S HOME DRUG TESTING SYSTEM. DR. BROWN'S HOME DRUG TESTING SYSTEM IS AN OVER-THE-COUNTER COLLECTION AND TRANSPORT SYSTEM INTENDED FOR USE BY INDIVIDUALS WISHING TO ANONYMOUSLY TEST URINE SAMPLES FOR DRUGS OF ABUSE (MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, PHYENCYCLIDINE (PCP), CODEINE, AND MORPHINE).
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