The following data is part of a premarket notification filed by Critical Care Diagnostics, Inc. (dba Critical Diag with the FDA for Presage St2 Assay.
| Device ID | K111452 |
| 510k Number | K111452 |
| Device Name: | PRESAGE ST2 ASSAY |
| Classification | St2 Assay |
| Applicant | CRITICAL CARE DIAGNOSTICS, INC. (DBA CRITICAL DIAG 3030 BUNKER HILL STREET SUITE 115A San Diego, CA 92109 |
| Contact | James Snider |
| Correspondent | James Snider CRITICAL CARE DIAGNOSTICS, INC. (DBA CRITICAL DIAG 3030 BUNKER HILL STREET SUITE 115A San Diego, CA 92109 |
| Product Code | OYG |
| CFR Regulation Number | 862.1117 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-25 |
| Decision Date | 2011-12-09 |
| Summary: | summary |