Cleared Traditional

ELECSYS TROPONIN T STAT TEST

K984105 · Boehringer Mannheim Corp. · Chemistry
Dec 1998
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K984105 is an FDA 510(k) clearance for the ELECSYS TROPONIN T STAT TEST, a Immunoassay Method, Troponin Subunit (Class II — Special Controls, product code MMI), submitted by Boehringer Mannheim Corp. (Indianapolis,, US). The FDA issued a Cleared decision on December 8, 1998, 21 days after receiving the submission on November 17, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K984105 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 1998
Decision Date December 08, 1998
Days to Decision 21 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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