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510(k) K010158

THROMBOMAX-HS WITH CALCIUM, MODEL T6540 by Sigma Diagnostics, Inc. — Product Code GGO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2001
Date Received
January 17, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Thromboplastin And Control
Device Class
Class II
Regulation Number
864.7925
Review Panel
HE
Submission Type

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