Cleared Traditional

LIQUISPEX(TM) LIQUID B2M/CRP CONTROL LEVEL 1 AND 2

K946049 · Clinical Controls, Inc. · Chemistry
Feb 1995
Decision
60d
Days
Class 1
Risk

About This 510(k) Submission

K946049 is an FDA 510(k) clearance for the LIQUISPEX(TM) LIQUID B2M/CRP CONTROL LEVEL 1 AND 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 February 10, 1995, 60 days after receiving the submission on December 12, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K946049 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 1994
Decision Date February 10, 1995
Days to Decision 60 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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