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FDA 510(k)

ROCHE ABUSCREEN ONLINE FOR METHADONE

K-Number: K930928 · 1993-09-24

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1993-09-24
Product CodeDJR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ROCHE ABUSCREEN ONLINE FOR METHADONE 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 1993-09-24 under 510(k) number K930928. 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 ROCHE ABUSCREEN ONLINE FOR METHADONE?

ROCHE ABUSCREEN ONLINE FOR METHADONE is a medical device that received FDA 510(k) clearance on 1993-09-24. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K930928.

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

ROCHE ABUSCREEN ONLINE FOR METHADONE received FDA 510(k) clearance on 1993-09-24, under 510(k) number K930928.

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

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 METHADONE?

The FDA product code for ROCHE ABUSCREEN ONLINE FOR METHADONE is DJR.

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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: 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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