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510(k) K001943

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

K001943 is an FDA 510(k) premarket notification submitted by Sangui Biotech, Inc. for the device "CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY". The FDA issued a decision of Substantially Equivalent on August 23, 2000. The device falls under product code NAO (Test, Carbohydrate Deficient Transferrin), a Class I device regulated under 21 CFR 862.1360. Sangui Biotech, Inc. has at least 4 other 510(k) clearances on record.

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

Other clearances by Sangui Biotech, Inc.

  • K992799 — SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT (June 7, 2000)
  • K982491 — SANGUI BIOTECH, INC. CALCITONIN ELISA KIT (September 3, 1998)
  • 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

  • K060677 — N LATEX CDT (August 25, 2006)
  • K992502 — AXIS %CDT TURBIDIMETRIC IMMUNOASSAY (December 21, 1999)

FDA data resources