Cleared Traditional

AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM

K971103 · Tosoh Medics, Inc. · Chemistry
Jun 1997
Decision
93d
Days
Class 1
Risk

About This 510(k) Submission

K971103 is an FDA 510(k) clearance for the AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM, a Fluorometer, For Clinical Use (Class I — General Controls, product code KHO), submitted by Tosoh Medics, Inc. (Foster City, US). The FDA issued a Cleared decision on June 27, 1997, 93 days after receiving the submission on March 26, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2560.

Submission Details

510(k) Number K971103 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 1997
Decision Date June 27, 1997
Days to Decision 93 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code KHO — Fluorometer, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2560

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