Cleared Traditional

ELECSYS CALCHECK TROPONIN T

K984372 · Boehringer Mannheim Corp. · Chemistry
Dec 1998
Decision
7d
Days
Class 1
Risk

About This 510(k) Submission

K984372 is an FDA 510(k) clearance for the ELECSYS CALCHECK TROPONIN T, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Boehringer Mannheim Corp. (Indianapolis,, US). The FDA issued a Cleared decision on December 14, 1998, 7 days after receiving the submission on December 7, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K984372 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 1998
Decision Date December 14, 1998
Days to Decision 7 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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