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FDA 510(k)

URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE

K-Number: K950135 · 1995-03-30

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1995-03-30
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

URINE AMPHETAMINES 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 1995-03-30 under 510(k) number K950135. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE is a medical device that received FDA 510(k) clearance on 1995-03-30. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K950135.

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

URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE received FDA 510(k) clearance on 1995-03-30, under 510(k) number K950135.

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

The FDA product code for URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE is DKZ.

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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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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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