Ligand Plus Control Level 1-3

FDA 510(k) K033344 · Consolidated Technology

Substantially Equivalent

510(k) numberK033344

Submission

Device name
Ligand Plus Control Level 1-3
Applicant
Consolidated Technology
Austin, TX, US
Received
October 20, 2003
Decision date
January 16, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JJY – Multi-Analyte Controls, All Kinds (Assayed)
Device class
Class I (low risk)
Regulation
21 CFR 862.1660
Specialty
Clinical Chemistry

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More from Aalto Scientific, Ltd.

510(k)DeviceDecision
K023731Quickcheck Liquid Chemistry Control (Assayed and Unassayed), Levels 1, 2, and 3JJY · Traditional 12/24/2002SE
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K003716Conformance Chemistry Control C3JJY · Traditional 12/20/2000SE

Questions and answers

When was Ligand Plus Control Level 1-3 cleared by the FDA?

Ligand Plus Control Level 1-3 (K033344) received a 510(k) decision of Substantially Equivalent on January 16, 2004, 88 days after the submission was received.

What is the product code of K033344?

The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.