510(k) K111452
- Device
- PRESAGE ST2 ASSAY
- Applicant
- CRITICAL CARE DIAGNOSTICS, INC. (DBA CRITICAL DIAG
- 510(k) number
- K111452
- Product code
- OYG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-12-09
- Date received
- 2011-05-25
- Regulation
- 862.1117
- Classification name
- St2 Assay
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES SNIDER
- Address
- 3030 Bunker Hill St. Suite 115a San Diego CA US 92109 92109
FDA Registration Numbers#
- 3002800697
Source Documents#
Legacy Summary#
summary
FDA Review#
Decision Summary