Cleared Traditional

SERUM VOLATILES CONTROL LEVEL 1 & 2

K955691 · Clinical Controls, Inc. · Chemistry
Apr 1996
Decision
132d
Days
Class 1
Risk

About This 510(k) Submission

K955691 is an FDA 510(k) clearance for the SERUM VOLATILES CONTROL LEVEL 1 & 2, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Clinical Controls, Inc. (Grover Beach, US). The FDA issued a Cleared decision on April 24, 1996, 132 days after receiving the submission on December 14, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K955691 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 1995
Decision Date April 24, 1996
Days to Decision 132 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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