CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)
FDA 510(k) clearance K060578 · decided 2006-08-30
Clearance details
- K-number
- K060578
- Device name
- CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)
- Applicant
- Scantibodies Laboratory, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-03-06
- Decision date
- 2006-08-30
- Days to decision
- 177 days
- Clearance type
- Traditional
- Product code
- JKR
- Device class
- 2
- Regulation number
- 862.1140
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Santee, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.