Cleared Traditional

VITROS Immunodiagnostic Products CK-MB Reagent Pack

K212648 · Ortho-Clinical Diagnostics · Chemistry
Jan 2022
Decision
158d
Days
Class 2
Risk

About This 510(k) Submission

K212648 is an FDA 510(k) clearance for the VITROS Immunodiagnostic Products CK-MB Reagent Pack, a Fluorometric Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHX), submitted by Ortho-Clinical Diagnostics (Pencoed, GB). The FDA issued a Cleared decision on January 28, 2022, 158 days after receiving the submission on August 23, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K212648 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2021
Decision Date January 28, 2022
Days to Decision 158 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JHX — Fluorometric Method, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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