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510(k) K900939

SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.) by Incstar Corp. — Product Code KQJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1990
Date Received
February 28, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Fibrinogen Determination
Device Class
Class II
Regulation Number
864.7340
Review Panel
HE
Submission Type

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