Cleared Traditional

IMMUSURE

K973894 · Quantimetrix Corp. · Chemistry
Oct 1997
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K973894 is an FDA 510(k) clearance for the IMMUSURE, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Quantimetrix Corp. (Redondo, US). The FDA issued a Cleared decision on October 29, 1997, 15 days after receiving the submission on October 14, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K973894 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 1997
Decision Date October 29, 1997
Days to Decision 15 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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