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FDA 510(k)

COBAS LITHIUM

K-Number: K063684 · 2008-03-21

ApplicantRoche Diagnostics Corp.
Decision Date2008-03-21
Product CodeNDW
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COBAS LITHIUM 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 2008-03-21 under 510(k) number K063684. The device is classified under product code NDW. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS LITHIUM?

COBAS LITHIUM is a medical device that received FDA 510(k) clearance on 2008-03-21. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K063684.

When did COBAS LITHIUM receive FDA 510(k) clearance?

COBAS LITHIUM received FDA 510(k) clearance on 2008-03-21, under 510(k) number K063684.

Who is the listed applicant for COBAS LITHIUM?

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 LITHIUM?

The FDA product code for COBAS LITHIUM is NDW.

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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: NDW)

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.

K243462Diazyme Colorimetric Lithium AssayDiazyme Laboratories, Inc.K112142DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGESiemens Healthcare DiagnosticsK063705LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROLThermo Electron OYK070987SENTINEL LITHIUM ASSAYSENTINEL CH. SpAK050374ADVIA IMS LITHIUM ASSAYBayer Healthcare, LLCK003583LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901Trace America, 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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