The following data is part of a premarket notification filed by Kronus Market Development Associates, Inc. with the FDA for Kronus Voltage Gated Calcium Channel (vgcc) Antibody Ria Assay Kit.
| Device ID | K111956 |
| 510k Number | K111956 |
| Device Name: | KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT |
| Classification | Voltage Gated Calcium Channel (vgcc) Antibody Assay |
| Applicant | KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. 170 S SENECA SPRINGS WAY SUITE 105 Star, ID 83669 |
| Contact | Heather Viele |
| Correspondent | Heather Viele KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. 170 S SENECA SPRINGS WAY SUITE 105 Star, ID 83669 |
| Product Code | PAF |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-11 |
| Decision Date | 2012-05-30 |