510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001943Substantially Equivalent

Chronalco I.d.cdt (Carbohydrate Deficient Transferrin) Assay

Sangui Biotech, Inc., Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001943 is the FDA 510(k) clearance record for CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY, a class I device, cleared for Sangui Biotech, Inc. on under FDA product code NAO (Test, Carbohydrate Deficient Transferrin). FDA records list 5 510(k) clearances for Sangui Biotech, Inc., from to . As of , FDA records show no recalls naming K001943.

Clearance record

Decision date
Received
(58 days to decision)
Product code
NAO Test, Carbohydrate Deficient Transferrin
Regulation
21 CFR 862.1360
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Sangui Biotech, Inc. 1508 Brookhollow Dr., #354, Santa Ana CA
510(k) summary
Summary
Third party review
No

Clearances, product code NAO

Trailing 12 months

FDA records hold no clearances under product code NAO in the trailing twelve months.

FDA records show no clearances under product code NAO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NAO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260