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510(k) K051757

CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 by Diagnostic Chemicals , Ltd. — Product Code CJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2005
Date Received
June 29, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Azo Dye, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

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  • K041927 — LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 (November 23, 2004)

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