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FDA 510(k)

QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE

K-Number: K864993 · 1987-03-31

ApplicantGeneral Diagnostics
Decision Date1987-03-31
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE is the device name listed in this FDA 510(k) record. The listed applicant is General Diagnostics. It received FDA 510(k) clearance on 1987-03-31 under 510(k) number K864993. 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 QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE?

QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE is a medical device that received FDA 510(k) clearance on 1987-03-31. The listed applicant is General Diagnostics. The 510(k) number is K864993.

When did QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE receive FDA 510(k) clearance?

QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE received FDA 510(k) clearance on 1987-03-31, under 510(k) number K864993.

Who is the listed applicant for QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE?

The FDA 510(k) record lists General Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE?

The FDA product code for QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE is DIS.

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Other records listing General Diagnostics 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.

K882663BARBITURATE ENZYME IMMUNOASSAY KITK872882CANNABINOID ENZYME IMMUNOASSAY KITK871305COCAINE METABOLITE ENZYME IMMUNOASSAY KITK863877BENZODIAZEPINE ENZYME IMMUNOASSAY KITK842307GENERAL DIAG. CEFONICID 30MCG ANTIMICK841465GENERAL DIAGNOSTICS PLATELET ANTIBODY

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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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