
Sudormed, Inc.
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SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION is an FDA 510(k)-cleared medical device (K935564) manufactured by Sudormed, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 13, 1995. Regulation: 8.