Cleared Traditional

SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION

K935564 · Sudormed, Inc. · Toxicology
Jul 1995
Decision
603d
Days
Class 2
Risk

About This 510(k) Submission

K935564 is an FDA 510(k) clearance for the SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Sudormed, Inc. (Santa Ana, US). The FDA issued a Cleared decision on July 14, 1995, 603 days after receiving the submission on November 18, 1993. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K935564 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 1993
Decision Date July 14, 1995
Days to Decision 603 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1675

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