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FDA 510(k)

LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901

K-Number: K003583 · 2001-01-17

ApplicantTrace America, Inc.
Decision Date2001-01-17
Product CodeNDW
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 is the device name listed in this FDA 510(k) record. The listed applicant is Trace America, Inc.. It received FDA 510(k) clearance on 2001-01-17 under 510(k) number K003583. 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 LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901?

LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 is a medical device that received FDA 510(k) clearance on 2001-01-17. The listed applicant is Trace America, Inc.. The 510(k) number is K003583.

When did LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 receive FDA 510(k) clearance?

LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 received FDA 510(k) clearance on 2001-01-17, under 510(k) number K003583.

Who is the listed applicant for LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901?

The FDA 510(k) record lists Trace America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901?

The FDA product code for LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 is NDW.

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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 OYK070987SENTINEL LITHIUM ASSAYSENTINEL CH. SpAK050374ADVIA IMS LITHIUM ASSAYBayer Healthcare, LLC

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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