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FDA 510(k)

ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE

K-Number: K830461 · 1983-03-24

ApplicantHoffmann-La Roche, Inc.
Decision Date1983-03-24
Product CodeKXS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE is the device name listed in this FDA 510(k) record. The listed applicant is Hoffmann-La Roche, Inc.. It received FDA 510(k) clearance on 1983-03-24 under 510(k) number K830461. 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 ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE?

ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is Hoffmann-La Roche, Inc.. The 510(k) number is K830461.

When did ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE receive FDA 510(k) clearance?

ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE received FDA 510(k) clearance on 1983-03-24, under 510(k) number K830461.

Who is the listed applicant for ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE?

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

What is the FDA product code for ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE?

The FDA product code for ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE is KXS.

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Other records listing Hoffmann-La Roche, 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.

K850727BHCG-ROCHE EIAK831694RENAKK830462ABUSCREEN RADIOUMMUNOASSAY--URINEK830480ABUSCREEN RADIOIMMUNOASSAY-COCAINE METAK830482ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINEK830481ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE

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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.K945187ROCHE ABUSCREEN ONLINE FOR METHAQUALONERoche Diagnostic Systems, Inc.K940123METHAQUALONE ENZYME IMMUNOASSAYDiagnostic Reagents, Inc.K921013SYVA EMIT II METHAQUALONE ASSAYSyva Co.

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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