WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY— 510(k) K041155
Substantially EquivalentStanbio Laboratory
FDA 510(k) clearance K041155 for WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY, Substantially Equivalent on 2004-10-14. Applicant: Stanbio Laboratory. Device class: 2.
Clearance details
- Applicant
- Stanbio Laboratory
- Product code
- Code DCK
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boerne, TX, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.