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510(k) K964452

HEMATACHEK by Richmond Diagnostics, Inc. — Product Code GLK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1997
Date Received
November 6, 1996
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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