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510(k) K924926

MSI-HCT by Medical Specialties, Inc. — Product Code GLK

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 7, 1993
Date Received: September 30, 1992
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Control, Hematocrit
Device Class: Class II
Regulation Number: 864.8625
Review Panel: HE
Submission Type

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