Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GEM Premier 3000

K-Number: K161818 · 2016-09-14

ApplicantInstrumentation Laboratory CO
Decision Date2016-09-14
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GEM Premier 3000 is a medical device manufactured by Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2016-09-14 under approval number K161818. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEM Premier 3000?

GEM Premier 3000 is a medical device that received FDA 510(k) clearance on 2016-09-14. It is manufactured by Instrumentation Laboratory CO. The 510(k) number is K161818.

When was GEM Premier 3000 approved by the FDA?

GEM Premier 3000 received FDA 510(k) clearance on 2016-09-14, under approval number K161818.

What company makes GEM Premier 3000?

GEM Premier 3000 is manufactured by Instrumentation Laboratory CO.

What is the FDA product code for GEM Premier 3000?

The FDA product code for GEM Premier 3000 is CGA.

Other Devices by Instrumentation Laboratory CO

K160225GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator K160415GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) K160412GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) K160885HemosIL D-Dimer HS K153137HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls

View all 26 devices →

Related Devices (Code: CGA)

K162282CardioChek Plus Test System, CardioChek Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)Instrumentation Laboratory CO K153692Synermed Glucose Reagent, Synermed IR-1200 Chemistry AnalyzerInfrared Laboratory Systems, LLC (Dba Synermed) K163433VITROS Chemistry Products GLU SlidesOrtho Clinical Diagnostics K163271i-Stat Alinity System with i-Stat Glucose testAbbott Point of Care, Inc. K182781PTS Professional Chemistry KitPolymer Technology Systems, Inc. D/B/A Pts Diagnostics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑