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FDA 510(k)

SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE

K-Number: K926253 · 1995-07-14

ApplicantSudormed, Inc.
Decision Date1995-07-14
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE 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 K926253. 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: COCAINE?

SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE 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 K926253.

When did SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE receive FDA 510(k) clearance?

SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE received FDA 510(k) clearance on 1995-07-14, under 510(k) number K926253.

Who is the listed applicant for SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE?

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: COCAINE?

The FDA product code for SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE is JKA.

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Other records listing Sudormed, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K936135SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATIONK936240SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE)K935588SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF AMPHETAMINES IN PERSPIRATIONK935564SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATIONK902442SUDORMED SWEAT PATCH SPECIMEN CONTAINER

Related Devices (Code: JKA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262215Profoject™ Safety Sliding Blood Collection SetCMT Health PTE., Ltd.K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and CompanyK252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and CompanyK252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and CompanyK252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and Company

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.

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