Cleared Traditional

LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2

K946050 · Clinical Controls, Inc. · Immunology
Feb 1995
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K946050 is an FDA 510(k) clearance for the LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2, a C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code DCK), 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 Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K946050 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 Immunology (IM)
Summary Statement

Device Classification

Product Code DCK — C-reactive Protein, Antigen, Antiserum, And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5270

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