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510(k) K931721

IL TEST FIBRINOGEN-C by Instrumentation Laboratory CO — Product Code KQJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1993
Date Received
April 7, 1993
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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Other clearances for product code KQJ

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  • K922416 — FIBRINOGEN RID TEST KIT (March 9, 1993)
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  • K923593 — HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS (September 22, 1992)