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FDA 510(k)

ABUSCREEN (R) EIA BARBITURATE

K-Number: K870378 · 1987-03-16

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1987-03-16
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ABUSCREEN (R) EIA BARBITURATE is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1987-03-16 under 510(k) number K870378. 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 ABUSCREEN (R) EIA BARBITURATE?

ABUSCREEN (R) EIA BARBITURATE is a medical device that received FDA 510(k) clearance on 1987-03-16. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K870378.

When did ABUSCREEN (R) EIA BARBITURATE receive FDA 510(k) clearance?

ABUSCREEN (R) EIA BARBITURATE received FDA 510(k) clearance on 1987-03-16, under 510(k) number K870378.

Who is the listed applicant for ABUSCREEN (R) EIA BARBITURATE?

The FDA 510(k) record lists Roche Diagnostic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABUSCREEN (R) EIA BARBITURATE?

The FDA product code for ABUSCREEN (R) EIA BARBITURATE is DIS.

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Other records listing Roche Diagnostic Systems, 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.

K983698MODIFICATION TO ABUSCREEN ONLINE BARBITURATESK983702MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINESK983704MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINEK983556ABUSCREEN ONLINE BENZ 300 CALIBRATORSK983555ABUSCREEN ONLINE BENZ 200 CALIBRATORSK983700MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE

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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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