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510(k) K950469

DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET by Casco Standards — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 1995
Date Received
February 3, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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