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510(k) K945718

DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET by Casco Standards — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1995
Date Received
November 21, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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