Cleared Traditional

SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION

K936135 · Sudormed, Inc. · Chemistry
Jun 1996
Decision
895d
Days
Class 2
Risk

About This 510(k) Submission

K936135 is an FDA 510(k) clearance for the SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION, a Radioimmunoassay, Cannabinoid(s) (Class II — Special Controls, product code LAT), submitted by Sudormed, Inc. (Santa Ana, US). The FDA issued a Cleared decision on June 10, 1996, 895 days after receiving the submission on December 28, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K936135 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 1993
Decision Date June 10, 1996
Days to Decision 895 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code LAT — Radioimmunoassay, Cannabinoid(s)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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