Cleared Traditional

ONTRAK TESTCUP AND TESTSTIK CONTROLS

K983387 · Roche Diagnostic Systems, Inc. · Chemistry
Oct 1998
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K983387 is an FDA 510(k) clearance for the ONTRAK TESTCUP AND TESTSTIK CONTROLS, a Drug Mixture Control Materials (Class I — General Controls, product code DIF), submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on October 9, 1998, 14 days after receiving the submission on September 25, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K983387 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 1998
Decision Date October 09, 1998
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code DIF — Drug Mixture Control Materials
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3280

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