Cleared Traditional

Atellica? CH HDL Cholesterol (HDLC)& Atellica? CH LDL Cholesterol (LDLC)

K241800 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Jul 2024
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K241800 is an FDA 510(k) clearance for the Atellica? CH HDL Cholesterol (HDLC)& Atellica? CH LDL Cholesterol (LDLC), a System, Test, Low Density, Lipoprotein (Class I — General Controls, product code MRR), submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on July 26, 2024, 35 days after receiving the submission on June 21, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K241800 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2024
Decision Date July 26, 2024
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MRR — System, Test, Low Density, Lipoprotein
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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