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FDA 510(k)

AGGLUTEX METHAQUALONE TEST KIT

K-Number: K812987 · 1981-12-22

ApplicantHoffmann-La Roche, Inc.
Decision Date1981-12-22
Product CodeKXS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AGGLUTEX METHAQUALONE TEST KIT 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 1981-12-22 under 510(k) number K812987. 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 AGGLUTEX METHAQUALONE TEST KIT?

AGGLUTEX METHAQUALONE TEST KIT is a medical device that received FDA 510(k) clearance on 1981-12-22. The listed applicant is Hoffmann-La Roche, Inc.. The 510(k) number is K812987.

When did AGGLUTEX METHAQUALONE TEST KIT receive FDA 510(k) clearance?

AGGLUTEX METHAQUALONE TEST KIT received FDA 510(k) clearance on 1981-12-22, under 510(k) number K812987.

Who is the listed applicant for AGGLUTEX METHAQUALONE TEST KIT?

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 AGGLUTEX METHAQUALONE TEST KIT?

The FDA product code for AGGLUTEX METHAQUALONE TEST KIT 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-AMPHETAMINEK830461ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE

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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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