SANGUI BIOTECH, INC. CALCITONIN ELISA KIT
FDA 510(k) clearance K982491 · decided 1998-09-03
Clearance details
- K-number
- K982491
- Device name
- SANGUI BIOTECH, INC. CALCITONIN ELISA KIT
- Applicant
- Sangui Biotech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-07-17
- Decision date
- 1998-09-03
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- JKR
- Device class
- 2
- Regulation number
- 862.1140
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitat recall (Z-0467-2015) | Biomerica | 2014-12-16 |