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510(k) K992502

AXIS %CDT TURBIDIMETRIC IMMUNOASSAY by Axis — Product Code NAO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 21, 1999
Date Received: July 26, 1999
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Test, Carbohydrate Deficient Transferrin
Device Class: Class I
Regulation Number: 862.1360
Review Panel: CH
Submission Type