Cleared Traditional

SPINALSCOPICS

K970862 · Quantimetrix Corp. · Chemistry
Apr 1997
Decision
32d
Days
Class 1
Risk

About This 510(k) Submission

K970862 is an FDA 510(k) clearance for the SPINALSCOPICS, 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 April 8, 1997, 32 days after receiving the submission on March 7, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K970862 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 1997
Decision Date April 08, 1997
Days to Decision 32 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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