Lacrytest

FDA 510(k) K034057 · Adiatec SA

Substantially Equivalent

510(k) numberK034057

Submission

Device name
Lacrytest
Applicant
Adiatec SA
Nantes, FR
Received
December 30, 2003
Decision date
March 9, 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
DGC – Ige, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5510
Specialty
Immunology

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K063425Dimension Vista Ige Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control…DGC · Traditional Dade Behring, Inc.02/15/2007SE
K050493Quantia IgeDGC · Traditional Biokit, S.A.08/16/2005SE
K042241K-Assay Total Ige, K-Assay Ige Calibrator Set, Models KAI-092/KAI-093CDGC · Traditional Kamiya Biomedical Co.12/10/2004SE
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Questions and answers

When was Lacrytest cleared by the FDA?

Lacrytest (K034057) received a 510(k) decision of Substantially Equivalent on March 9, 2004, 70 days after the submission was received.

What is the product code of K034057?

The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.