510(k) K001943
- Device
- CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY
- Applicant
- SANGUI BIOTECH, INC.
- 510(k) number
- K001943
- Product code
- NAO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-08-23
- Date received
- 2000-06-26
- Regulation
- 862.1360
- Classification name
- Test, Carbohydrate Deficient Transferrin
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN J KIANG
- Address
- 1508 Brookhollow Dr., #354 Santa Ana CA US 92705 92705
FDA Registration Numbers#
- 9610806
- 3014325803
- 8023024
Source Documents#
Other 510(k) Records For Product Code NAO #
Legacy Summary#
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FDA Review#
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