CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY
FDA 510(k) clearance K001943 · decided 2000-08-23
Clearance details
- K-number
- K001943
- Device name
- CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY
- Applicant
- Sangui Biotech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-06-26
- Decision date
- 2000-08-23
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- NAO
- Device class
- 1
- Regulation number
- 862.1360
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| N LATEX CDT (K060677) | Dade Behring, Inc. | 2006-08-25 |
| AXIS %CDT TURBIDIMETRIC IMMUNOASSAY (K992502) | Axis | 1999-12-21 |
Recalls involving this device
No recalls on record reference this clearance.