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510(k) K060677

N LATEX CDT by Dade Behring, Inc. — Product Code NAO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2006
Date Received
March 14, 2006
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

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Other clearances for product code NAO

  • K001943 — CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY (August 23, 2000)
  • K992502 — AXIS %CDT TURBIDIMETRIC IMMUNOASSAY (December 21, 1999)