510(k) K111956
- Device
- KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT
- Applicant
- KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
- 510(k) number
- K111956
- Product code
- PAF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-05-30
- Date received
- 2011-07-11
- Regulation
- 866.5660
- Classification name
- Voltage Gated Calcium Channel (vgcc) Antibody Assay
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- HEATHER VIELE
- Address
- 170 S. Seneca Springs Way Suite 105 Star ID US 83669 83669
FDA Registration Numbers#
- 3003834021
- 2025560
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
Decision Summary