Cleared Traditional

Diazyme DZ-Lite Total beta-hCG Test System

K163418 · Diazyme Laboratories · Chemistry
Aug 2017
Decision
255d
Days
Class 2
Risk

About This 510(k) Submission

K163418 is an FDA 510(k) clearance for the Diazyme DZ-Lite Total beta-hCG Test System, a System, Test, Human Chorionic Gonadotropin (Class II — Special Controls, product code DHA), submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on August 18, 2017, 255 days after receiving the submission on December 6, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K163418 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2016
Decision Date August 18, 2017
Days to Decision 255 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code DHA — System, Test, Human Chorionic Gonadotropin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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