Cleared Traditional

INNOFLOUR CALIBRATOR REAGENT SET

K970509 · Oxis Intl., Inc. · Toxicology
May 1997
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K970509 is an FDA 510(k) clearance for the INNOFLOUR CALIBRATOR REAGENT SET, a Calibrators, Drug Specific (Class II — Special Controls, product code DLJ), submitted by Oxis Intl., Inc. (Portland, US). The FDA issued a Cleared decision on May 12, 1997, 90 days after receiving the submission on February 11, 1997. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K970509 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 1997
Decision Date May 12, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DLJ — Calibrators, Drug Specific
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3200

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