FDA 510(k)

SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION

K-Number: K935564 · 1995-07-14

Decision Date1995-07-14

Product CodeJKA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION is the device name listed in this FDA 510(k) record. The listed applicant is Sudormed, Inc.. It received FDA 510(k) clearance on 1995-07-14 under 510(k) number K935564. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION?

SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION is a medical device that received FDA 510(k) clearance on 1995-07-14. The listed applicant is Sudormed, Inc.. The 510(k) number is K935564.

When did SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION receive FDA 510(k) clearance?

SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION received FDA 510(k) clearance on 1995-07-14, under 510(k) number K935564.

Who is the listed applicant for SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION?

The FDA 510(k) record lists Sudormed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION?

The FDA product code for SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION is JKA.

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Other records listing Sudormed, Inc. as applicant

K936135SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION K936240SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE)K926253SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE K935588SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF AMPHETAMINES IN PERSPIRATION K902442SUDORMED SWEAT PATCH SPECIMEN CONTAINER

Related Devices (Code: JKA)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.