Cleared Traditional

CANNU-SKREEN-PRELIMINARY

K841831 · Biochemical Diagnostic, Inc. · Toxicology
Jul 1984
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K841831 is an FDA 510(k) clearance for the CANNU-SKREEN-PRELIMINARY, a Reagents, Test, Tetrahydrocannabinol (Class II — Special Controls, product code DKE), submitted by Biochemical Diagnostic, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1984, 64 days after receiving the submission on May 3, 1984. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K841831 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 1984
Decision Date July 06, 1984
Days to Decision 64 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DKE — Reagents, Test, Tetrahydrocannabinol
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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