KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT
FDA 510(k) clearance K111956 · decided 2012-05-30
Clearance details
- K-number
- K111956
- Device name
- KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT
- Applicant
- Kronus Market Development Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-07-11
- Decision date
- 2012-05-30
- Days to decision
- 324 days
- Clearance type
- Traditional
- Product code
- PAF
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Star, ID, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.