Cleared Traditional

V8 SP NORMAL CONTROL, ABNORMAL CONTROL

K131479 · Helena Laboratories · Immunology
Oct 2013
Decision
138d
Days
Class 1
Risk

About This 510(k) Submission

K131479 is an FDA 510(k) clearance for the V8 SP NORMAL CONTROL, ABNORMAL CONTROL, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on October 7, 2013, 138 days after receiving the submission on May 22, 2013. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K131479 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2013
Decision Date October 07, 2013
Days to Decision 138 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

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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