Diazyme 1,5-AG Assay— 510(k) K180209
Substantially EquivalentDiazyme Laboratories, Inc.
FDA 510(k) clearance K180209 for Diazyme 1,5-AG Assay, Substantially Equivalent on 2018-10-04. Applicant: Diazyme Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Diazyme Laboratories, Inc.
- Product code
- Code NOZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.7470
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Poway, CA, US
Recent devices under product code NOZ
view allMore clearances from Diazyme Laboratories, Inc.
view all- K253069 — Lipoprotein (a) Molarity Assay
- K252336 — Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay
- K253358 — Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay
- K243462 — Diazyme Colorimetric Lithium Assay
- K211648 — Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
Data sourced from openFDA. This site is unofficial and independent of the FDA.