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FDA 510(k)

ACA BARBITURATES SCREEN ANALY TEST PACK

K-Number: K842783 · 1984-09-07

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1984-09-07
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACA BARBITURATES SCREEN ANALY 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 1984-09-07 under 510(k) number K842783. The device is classified under product code DIS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACA BARBITURATES SCREEN ANALY TEST PACK?

ACA BARBITURATES SCREEN ANALY TEST PACK is a medical device that received FDA 510(k) clearance on 1984-09-07. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K842783.

When did ACA BARBITURATES SCREEN ANALY TEST PACK receive FDA 510(k) clearance?

ACA BARBITURATES SCREEN ANALY TEST PACK received FDA 510(k) clearance on 1984-09-07, under 510(k) number K842783.

Who is the listed applicant for ACA BARBITURATES SCREEN ANALY 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 ACA BARBITURATES SCREEN ANALY TEST PACK?

The FDA product code for ACA BARBITURATES SCREEN ANALY TEST PACK is DIS.

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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: DIS)

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.

K161714Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis CorporationK092268RANDOX BARITURATES ASSAYRandox Laboratories, Ltd.K110515UCP DRUG SCREENING TEST CUPSUcp Biosciences, Inc.K070098QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SCPhamatech, Inc.K070009AT HOME DRUG TEST MODELS, 9308T AND 9308XPhamatech, Inc.K062165VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERSOrtho-Clinical Diagnostics

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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