Cleared Traditional

Atellica IM Total hCG (ThCG)

K172322 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Mar 2018
Decision
240d
Days
Class 2
Risk

About This 510(k) Submission

K172322 is an FDA 510(k) clearance for the Atellica IM Total hCG (ThCG), a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on March 29, 2018, 240 days after receiving the submission on August 1, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K172322 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2017
Decision Date March 29, 2018
Days to Decision 240 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JHI — Visual, Pregnancy Hcg, Prescription Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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