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510(k) K001943

CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY by Sangui Biotech, Inc. — Product Code NAO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2000
Date Received
June 26, 2000
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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  • K982608 — SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT (August 19, 1998)
  • K974306 — SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA (December 23, 1997)

Other clearances for product code NAO

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  • K992502 — AXIS %CDT TURBIDIMETRIC IMMUNOASSAY (December 21, 1999)