Cleared Traditional

STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.

K051650 · Dade Behring, Inc. · Chemistry
Sep 2005
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K051650 is an FDA 510(k) clearance for the STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK., a Fluorometric Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHX), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on September 8, 2005, 79 days after receiving the submission on June 21, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K051650 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2005
Decision Date September 08, 2005
Days to Decision 79 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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