510(k) K060578
K060578 is an FDA 510(k) premarket notification submitted by Scantibodies Laboratory, Inc. for the device "CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)". The FDA issued a decision of Substantially Equivalent on August 30, 2006. The device falls under product code JKR (Radioimmunoassay, Calcitonin), a Class II device regulated under 21 CFR 862.1140. Scantibodies Laboratory, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 30, 2006
- Date Received
- March 6, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Calcitonin
- Device Class
- Class II
- Regulation Number
- 862.1140
- Review Panel
- CH
- Submission Type