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FDA 510(k)

PROTRIPTYLINE TRI-CY TEST SET

K-Number: K821653 · 1982-06-14

ApplicantWien Laboratories, Inc.
Decision Date1982-06-14
Product CodeLFG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PROTRIPTYLINE TRI-CY TEST SET is the device name listed in this FDA 510(k) record. The listed applicant is Wien Laboratories, Inc.. It received FDA 510(k) clearance on 1982-06-14 under 510(k) number K821653. The device is classified under product code LFG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTRIPTYLINE TRI-CY TEST SET?

PROTRIPTYLINE TRI-CY TEST SET is a medical device that received FDA 510(k) clearance on 1982-06-14. The listed applicant is Wien Laboratories, Inc.. The 510(k) number is K821653.

When did PROTRIPTYLINE TRI-CY TEST SET receive FDA 510(k) clearance?

PROTRIPTYLINE TRI-CY TEST SET received FDA 510(k) clearance on 1982-06-14, under 510(k) number K821653.

Who is the listed applicant for PROTRIPTYLINE TRI-CY TEST SET?

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

What is the FDA product code for PROTRIPTYLINE TRI-CY TEST SET?

The FDA product code for PROTRIPTYLINE TRI-CY TEST SET is LFG.

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Other records listing Wien Laboratories, Inc. as applicant

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K912850SHBGK834246PROGESTERONE TEST SET 125I 17-OHK832452ANDROSTENEDIONE TEST SET 125IK823200125 I-DEHYDROEPIANDROSTERONE SULFATEK821652DOXEPIN TRI-CY TEST SETK802728125I-TESTOSTERONE TEST SET

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Related Devices (Code: LFG)

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K112395WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TESTGuangzhou Wondfo Biotech Co., Ltd.K072062UCP MULTIPLE DRUG SCREEN TEST CUPSUcp Biosciences, Inc.K061457UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTSUcp Biosciences, Inc.K021526ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICEACON Laboratories, Inc.K011545VERDICT -II TCA, VERDICT-II MTDMedtox Diagnostics, Inc.K980249ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCAPrinceton BioMeditech Corp.

Official Source

View on FDA Database →

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

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