DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET— 510(k) K103557
Substantially EquivalentDiazyme Laboratories
FDA 510(k) clearance K103557 for DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET, Substantially Equivalent on 2011-04-27. Applicant: Diazyme Laboratories. Device class: 2.
Clearance details
- Applicant
- Diazyme Laboratories
- 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
- Poway, CA, US
Recent devices under product code DCK
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.