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510(k) K070987

SENTINEL LITHIUM ASSAY by SENTINEL CH. SpA — Product Code NDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2007
Date Received
April 6, 2007
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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Other clearances for product code NDW

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  • K050374 — ADVIA IMS LITHIUM ASSAY (June 15, 2005)
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