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FDA 510(k)

MODIF. OF EMIT URINE BARBITURATE

K-Number: K833577 · 1984-01-26

ApplicantSyva Co.
Decision Date1984-01-26
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MODIF. OF EMIT URINE BARBITURATE is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1984-01-26 under 510(k) number K833577. 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 MODIF. OF EMIT URINE BARBITURATE?

MODIF. OF EMIT URINE BARBITURATE is a medical device that received FDA 510(k) clearance on 1984-01-26. The listed applicant is Syva Co.. The 510(k) number is K833577.

When did MODIF. OF EMIT URINE BARBITURATE receive FDA 510(k) clearance?

MODIF. OF EMIT URINE BARBITURATE received FDA 510(k) clearance on 1984-01-26, under 510(k) number K833577.

Who is the listed applicant for MODIF. OF EMIT URINE BARBITURATE?

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

What is the FDA product code for MODIF. OF EMIT URINE BARBITURATE?

The FDA product code for MODIF. OF EMIT URINE BARBITURATE is DIS.

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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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