Cleared Traditional

PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR

K000851 · Psychemedics Corp. · Toxicology
Dec 2000
Decision
271d
Days
Class 2
Risk

About This 510(k) Submission

K000851 is an FDA 510(k) clearance for the PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Psychemedics Corp. (Cambridge, US). The FDA issued a Cleared decision on December 11, 2000, 271 days after receiving the submission on March 15, 2000. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K000851 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2000
Decision Date December 11, 2000
Days to Decision 271 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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