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FDA 510(k)

DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK

K-Number: K934147 · 1993-11-09

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1993-11-09
Product CodeDJR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK 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 1993-11-09 under 510(k) number K934147. The device is classified under product code DJR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK?

DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK is a medical device that received FDA 510(k) clearance on 1993-11-09. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K934147.

When did DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK receive FDA 510(k) clearance?

DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK received FDA 510(k) clearance on 1993-11-09, under 510(k) number K934147.

Who is the listed applicant for DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK?

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 DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK?

The FDA product code for DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK is DJR.

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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

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Related Devices (Code: DJR)

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.

K192433LZI Methadone II Enzyme ImmunoassayLin-Zhi International, Inc.K182779ARK EDDP AssayArk Diagnostics, Inc.K170416LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) CalibratorsLin-Zhi International, Inc.K160793First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)W.H.P.M., Inc.K131232WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)Guangzhou Wondfo Biotech Co., Ltd.K092272RANDOX METHADONE ASSAYRandox Laboratories, Ltd.

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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