DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET— 510(k) K133083
Substantially EquivalentDiazyme Laboratories
FDA 510(k) clearance K133083 for DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET, Substantially Equivalent on 2014-06-24. Applicant: Diazyme Laboratories. Device class: 2.
Clearance details
- Applicant
- Diazyme Laboratories
- Product code
- Code DBF
- Device class
- Class 2
- Regulation
- 21 CFR 866.5340
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Poway, CA, US
Recent devices under product code DBF
view allMore clearances from Diazyme Laboratories
view all- K172992 — Diazyme EZ Vitamin D Assay
- K163418 — Diazyme DZ-Lite Total beta-hCG Test System
- K162297 — Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set
- K160762 — Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set
- K153394 — Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator
Data sourced from openFDA. This site is unofficial and independent of the FDA.