Note: 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. |
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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 | S003 |
Date Received | 06/10/1997 |
Decision Date | 08/15/1997 |
Product Code |
LDJ |
Advisory Committee |
Toxicology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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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