Cera-Chek 1070 Blood Glucose Monitoring System

FDA 510(k) K131727 · Ceragem Medisys, Inc.

Substantially Equivalent

510(k) numberK131727

Submission

Device name
Cera-Chek 1070 Blood Glucose Monitoring System
Applicant
Ceragem Medisys, Inc.
Cheonan Si, Chungcheongnam-Do, KR
Received
June 12, 2013
Decision date
February 28, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LFR – Glucose Dehydrogenase, Glucose
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1345
Specialty
Clinical Chemistry

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K113307GL Goodlife Series Blood Glucose Monitoring SysmtemLFR · Traditional Hmd Biomedical, Inc.07/27/2012SE

More from Hmd Biomedical, Inc.

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K141829Glucovitaal H1A Blood Glucose Monitoring SystemNBW · Special 09/24/2014SE
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Questions and answers

When was Cera-Chek 1070 Blood Glucose Monitoring System cleared by the FDA?

Cera-Chek 1070 Blood Glucose Monitoring System (K131727) received a 510(k) decision of Substantially Equivalent on February 28, 2014, 261 days after the submission was received.

What is the product code of K131727?

The FDA product code is LFR – Glucose Dehydrogenase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.