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FDA 510(k)

URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE

K-Number: K950182 · 1995-03-21

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1995-03-21
Product CodeDIW
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE 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 1995-03-21 under 510(k) number K950182. The device is classified under product code DIW. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE?

URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE is a medical device that received FDA 510(k) clearance on 1995-03-21. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K950182.

When did URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE receive FDA 510(k) clearance?

URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE received FDA 510(k) clearance on 1995-03-21, under 510(k) number K950182.

Who is the listed applicant for URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE?

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 URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE?

The FDA product code for URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE is DIW.

Related Clinical Trials

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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: DIW)

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.

K930845ROCHE ABUSCREEN ONTRAK FOR METHADONERoche Diagnostic Systems, Inc.K801509HI-M-TEST FOR METHADONE TEST #2Technam, Inc.K760075KIT, METHADONE (TOXI-PAK IMMUNO HI)J.T. Baker Chemical Co.

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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