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Found 2 results

510(k) Data Aggregation

K Number

Device Name

SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION

Manufacturer

Date Cleared

1996-06-10

(895 days)

Product Code

Regulation Number

Type

Panel

Clinical Chemistry

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

SUDORMED, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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Ask a specific question about this device

K Number

Device Name

SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE)

Manufacturer

Date Cleared

1996-03-19

(810 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

SUDORMED, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

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