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FDA 510(k)

SENTINEL LITHIUM ASSAY

K-Number: K070987 · 2007-08-02

ApplicantSENTINEL CH. SpA
Decision Date2007-08-02
Product CodeNDW
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SENTINEL LITHIUM ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is SENTINEL CH. SpA. It received FDA 510(k) clearance on 2007-08-02 under 510(k) number K070987. 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 SENTINEL LITHIUM ASSAY?

SENTINEL LITHIUM ASSAY is a medical device that received FDA 510(k) clearance on 2007-08-02. The listed applicant is SENTINEL CH. SpA. The 510(k) number is K070987.

When did SENTINEL LITHIUM ASSAY receive FDA 510(k) clearance?

SENTINEL LITHIUM ASSAY received FDA 510(k) clearance on 2007-08-02, under 510(k) number K070987.

Who is the listed applicant for SENTINEL LITHIUM ASSAY?

The FDA 510(k) record lists SENTINEL CH. SpA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENTINEL LITHIUM ASSAY?

The FDA product code for SENTINEL LITHIUM ASSAY is NDW.

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Other records listing SENTINEL CH. SpA 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.

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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 DiagnosticsK063684COBAS LITHIUMRoche Diagnostics Corp.K063705LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROLThermo Electron OYK050374ADVIA 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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