Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set— 510(k) K162297
Substantially EquivalentDiazyme Laboratories
FDA 510(k) clearance K162297 for Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set, Substantially Equivalent on 2017-04-18. Applicant: Diazyme Laboratories.
Clearance details
- Applicant
- Diazyme Laboratories
- Product code
- Code PTF
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Poway, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.