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510(k) K003583

LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 by Trace America, Inc. — Product Code NDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2001
Date Received
November 20, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Porphyrin, Spectrophotometry, Lithium
Device Class
Class II
Regulation Number
862.3560
Review Panel
TX
Submission Type

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