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FDA 510(k)

ROCHE ABUSCREEN ONLINE FOR METHAQUALONE

K-Number: K945187 · 1995-04-05

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1995-04-05
Product CodeKXS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ROCHE ABUSCREEN ONLINE FOR METHAQUALONE 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 1995-04-05 under 510(k) number K945187. The device is classified under product code KXS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE ABUSCREEN ONLINE FOR METHAQUALONE?

ROCHE ABUSCREEN ONLINE FOR METHAQUALONE is a medical device that received FDA 510(k) clearance on 1995-04-05. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K945187.

When did ROCHE ABUSCREEN ONLINE FOR METHAQUALONE receive FDA 510(k) clearance?

ROCHE ABUSCREEN ONLINE FOR METHAQUALONE received FDA 510(k) clearance on 1995-04-05, under 510(k) number K945187.

Who is the listed applicant for ROCHE ABUSCREEN ONLINE FOR METHAQUALONE?

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 ROCHE ABUSCREEN ONLINE FOR METHAQUALONE?

The FDA product code for ROCHE ABUSCREEN ONLINE FOR METHAQUALONE is KXS.

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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: KXS)

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.

K011164MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229Syva Co., Dade Behring, Inc.K993986SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129ULSyva Co.K955676SYNCHRON SYSTEMS METHAQUALONE REAGENTBeckman Instruments, Inc.K940123METHAQUALONE ENZYME IMMUNOASSAYDiagnostic Reagents, Inc.K921013SYVA EMIT II METHAQUALONE ASSAYSyva Co.K874272REVISED LABELING FOR METHAQUALONE TEST KITRoche Diagnostic Systems, Inc.

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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