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510(k) K993853

K-ASSAY MULTI-ANALYTE CALIBRATOR by Kamiya Biomedical Co. — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1999
Date Received
November 12, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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