Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set— 510(k) K162297

Name: FDA 510(k) clearance K162297
Creator: U.S. Food and Drug Administration
Published: 2017-04-18

Substantially Equivalent

Diazyme 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. Device class: 2.

Clearance details

Applicant: Diazyme Laboratories
Product code: Code PTF
Device class: Class 2
Regulation: 21 CFR 866.3215
Advisory panel: Microbiology
Date received: 2016-08-16
Decision date: 2017-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poway, CA, US

Download summary PDF View on FDA.gov ↗

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