SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION— 510(k) K935564

Substantially Equivalent

Sudormed, Inc.

FDA 510(k) clearance K935564 for SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION, Substantially Equivalent on 1995-07-14. Applicant: Sudormed, Inc..

Clearance details

Applicant: Sudormed, Inc.
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 1993-11-18
Decision date: 1995-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

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Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.