Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set— 510(k) K161721

Name: FDA 510(k) clearance K161721
Creator: U.S. Food and Drug Administration
Published: 2016-09-20

Substantially Equivalent

Diazyme Laboratories

FDA 510(k) clearance K161721 for Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set, Substantially Equivalent on 2016-09-20. Applicant: Diazyme Laboratories. Device class: 2.

Clearance details

Applicant: Diazyme Laboratories
Product code: Code CDD
Device class: Class 2
Regulation: 21 CFR 862.1810
Advisory panel: Clinical Chemistry
Date received: 2016-06-22
Decision date: 2016-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poway, CA, US

Download summary PDF View on FDA.gov ↗

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