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FDA 510(k)

COBAS INTEGRA ONLINE DAT II METHADONE II

K-Number: K021512 · 2002-07-16

ApplicantRoche Diagnostics Corp.
Decision Date2002-07-16
Product CodeDJR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COBAS INTEGRA ONLINE DAT II METHADONE II is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2002-07-16 under 510(k) number K021512. 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 COBAS INTEGRA ONLINE DAT II METHADONE II?

COBAS INTEGRA ONLINE DAT II METHADONE II is a medical device that received FDA 510(k) clearance on 2002-07-16. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K021512.

When did COBAS INTEGRA ONLINE DAT II METHADONE II receive FDA 510(k) clearance?

COBAS INTEGRA ONLINE DAT II METHADONE II received FDA 510(k) clearance on 2002-07-16, under 510(k) number K021512.

Who is the listed applicant for COBAS INTEGRA ONLINE DAT II METHADONE II?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COBAS INTEGRA ONLINE DAT II METHADONE II?

The FDA product code for COBAS INTEGRA ONLINE DAT II METHADONE II is DJR.

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Other records listing Roche Diagnostics Corp. 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.

K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMK101365ELECSYS CA 19-9 CALCHECK 5K100853COBAS 8000 MODULAR SERIES ANALYZERK101196ACCU-CHEK ULTRFLEX INFUSION SETK093664AMPHETAMINES II ASSAYK101075ELECSYS INSULIN CALCHECK 5

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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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