FDA 510(k)

GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)

K-Nummer: K160402 · 2016-12-14

AntragstellerInstrumentation Laboratory CO

Entscheidungsdatum2016-12-14

ProduktcodeCGA

BeratungsausschussCH

EntscheidungSubstantially Equivalent

Produktübersicht

GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2016-12-14 under 510(k) number K160402. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)?

GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) is a medical device that received FDA 510(k) clearance on 2016-12-14. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K160402.

When did GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) receive FDA 510(k) clearance?

GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) received FDA 510(k) clearance on 2016-12-14, under 510(k) number K160402.

Who is the listed applicant for GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)?

The FDA 510(k) record lists Instrumentation Laboratory CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)?

The FDA product code for GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) is CGA.

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Offizielle Quelle

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