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FDA 510(k)

METHAQUALONE ENZYME IMMUNOASSAY

K-Number: K940123 · 1994-05-03

ApplicantDiagnostic Reagents, Inc.
Decision Date1994-05-03
Product CodeKXS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

METHAQUALONE ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Reagents, Inc.. It received FDA 510(k) clearance on 1994-05-03 under 510(k) number K940123. 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 METHAQUALONE ENZYME IMMUNOASSAY?

METHAQUALONE ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1994-05-03. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K940123.

When did METHAQUALONE ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

METHAQUALONE ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1994-05-03, under 510(k) number K940123.

Who is the listed applicant for METHAQUALONE ENZYME IMMUNOASSAY?

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

What is the FDA product code for METHAQUALONE ENZYME IMMUNOASSAY?

The FDA product code for METHAQUALONE ENZYME IMMUNOASSAY is KXS.

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Other records listing Diagnostic Reagents, 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.

K983268MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAYK983812NAPA EIA ASSAYK983323DIGOXIN IMMUNOASSAYK983280VANCOMYCIN EIA ASSAYK983159DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLSK973102LIDOCAINE EIA ASSAY

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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.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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