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510(k) K900685

CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER by Texas Intl. Laboratories, Inc. — Product Code KQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1990
Date Received
February 12, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Coagulation
Device Class
Class II
Regulation Number
864.5400
Review Panel
HE
Submission Type

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