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FDA 510(k)

ACA TRICYCLIC ANTIDEPRESSANTS SCREEN TES

K-Number: K841532 · 1984-05-02

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1984-05-02
Product CodeLFG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACA TRICYCLIC ANTIDEPRESSANTS SCREEN TES is the device name listed in this FDA 510(k) record. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. It received FDA 510(k) clearance on 1984-05-02 under 510(k) number K841532. 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 ACA TRICYCLIC ANTIDEPRESSANTS SCREEN TES?

ACA TRICYCLIC ANTIDEPRESSANTS SCREEN TES is a medical device that received FDA 510(k) clearance on 1984-05-02. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K841532.

When did ACA TRICYCLIC ANTIDEPRESSANTS SCREEN TES receive FDA 510(k) clearance?

ACA TRICYCLIC ANTIDEPRESSANTS SCREEN TES received FDA 510(k) clearance on 1984-05-02, under 510(k) number K841532.

Who is the listed applicant for ACA TRICYCLIC ANTIDEPRESSANTS SCREEN TES?

The FDA 510(k) record lists E.I. Dupont DE Nemours & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACA TRICYCLIC ANTIDEPRESSANTS SCREEN TES?

The FDA product code for ACA TRICYCLIC ANTIDEPRESSANTS SCREEN TES is LFG.

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Other records listing E.I. Dupont DE Nemours & Co., 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.

K951851ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAYK953724CRONEX RADIATION THERAPY CASSETTEK953725CRONEX RADIATION THERAPY VERIFICATION CASSETTEK951441DUPONT ACA DIGOXIN (DGN A) METHODK950137URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGEK950136URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE

View all 253 devices →

Related Devices (Code: LFG)

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.

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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