Cleared Traditional

TROPONIN (TROP) METHOD

K973650 · Dade Chemistry Systems, Inc. · Chemistry
Oct 1997
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K973650 is an FDA 510(k) clearance for the TROPONIN (TROP) METHOD, a Immunoassay Method, Troponin Subunit (Class II — Special Controls, product code MMI), submitted by Dade Chemistry Systems, Inc. (Glasgow, US). The FDA issued a Cleared decision on October 20, 1997, 25 days after receiving the submission on September 25, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K973650 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 1997
Decision Date October 20, 1997
Days to Decision 25 days
Submission Type Traditional
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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