Cleared Traditional

K874156 - STICKER LABEL FOR DRUGS OF ABUSE ASSAYS (FDA 510(k) Clearance)

Oct 1987
Decision
15d
Days
Class 2
Risk

K874156 is an FDA 510(k) clearance for the STICKER LABEL FOR DRUGS OF ABUSE ASSAYS. This device is classified as a Enzyme Immunoassay, Cannabinoids (Class II - Special Controls, product code LDJ).

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on October 28, 1987, 15 days after receiving the submission on October 13, 1987.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K874156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1987
Decision Date October 28, 1987
Days to Decision 15 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary

Device Classification

Product Code LDJ — Enzyme Immunoassay, Cannabinoids
Device Class Class II - Special Controls
CFR Regulation 21 CFR 862.3870

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