Cleared Special

NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN

K102441 · Nano-Ditech Corporation · Chemistry
Oct 2010
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K102441 is an FDA 510(k) clearance for the NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN, a Immunoassay Method, Troponin Subunit (Class II — Special Controls, product code MMI), submitted by Nano-Ditech Corporation (Cranbury, US). The FDA issued a Cleared decision on October 20, 2010, 83 days after receiving the submission on July 29, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K102441 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2010
Decision Date October 20, 2010
Days to Decision 83 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MMI — Immunoassay Method, Troponin Subunit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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