Pathfast Ck-Mb-Ii, Pathfast Myo-Ii

FDA 510(k) K081360 · Mitsubishi Kagaku Iatron

Substantially Equivalent

510(k) numberK081360

Submission

Device name
Pathfast Ck-Mb-Ii, Pathfast Myo-Ii
Applicant
Mitsubishi Kagaku Iatron
Seattle, WA, US
Received
May 15, 2008
Decision date
August 17, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JHX – Fluorometric Method, Cpk Or Isoenzymes
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1215
Specialty
Clinical Chemistry

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K041596Architect Stat Ck-Mb ImmunoassayJHX · Traditional Fisher Diagnostics07/21/2004SE
K033747Ramp Ck-Mb AssayJHX · Traditional Response Biomedical Corp.05/17/2004SE
K034055Immulite 2500 Ck-Mb, 2500 Myoglobin, 2500 Stat Troponin IJHX · Special Diagnostic Products Corp.01/21/2004SE
K030012Ck-Mb and Ck-Mb Calibrators on the Access Immunoassay Systems, Models 386371 and 386372JHX · Special Beckman Coulter, Inc.01/17/2003SE
K022118Immulite Turbo Ck-Mb, Models LSKCP1 (100 Tests), LSKCP5 (500 Tests)JHX · Special Diagnostic Products Corp.07/22/2002SE

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Questions and answers

When was Pathfast Ck-Mb-Ii, Pathfast Myo-Ii cleared by the FDA?

Pathfast Ck-Mb-Ii, Pathfast Myo-Ii (K081360) received a 510(k) decision of Substantially Equivalent on August 17, 2009, 459 days after the submission was received.

What is the product code of K081360?

The FDA product code is JHX – Fluorometric Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.