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FDA 510(k)

METHADONE ENZYME IMMUNOASSAY

K-Number: K934667 · 1994-01-26

ApplicantDiagnostic Reagents, Inc.
Decision Date1994-01-26
Product CodeDJR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

METHADONE 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 1994-01-26 under 510(k) number K934667. The device is classified under product code DJR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the METHADONE ENZYME IMMUNOASSAY?

METHADONE ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1994-01-26. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K934667.

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

METHADONE ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1994-01-26, under 510(k) number K934667.

Who is the listed applicant for METHADONE 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 METHADONE ENZYME IMMUNOASSAY?

The FDA product code for METHADONE ENZYME IMMUNOASSAY is DJR.

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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: DJR)

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.

K192433LZI Methadone II Enzyme ImmunoassayLin-Zhi International, Inc.K182779ARK EDDP AssayArk Diagnostics, Inc.K170416LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) CalibratorsLin-Zhi International, Inc.K160793First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)W.H.P.M., Inc.K131232WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)Guangzhou Wondfo Biotech Co., Ltd.K092272RANDOX METHADONE ASSAYRandox Laboratories, Ltd.

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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