Cleared Traditional

GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)

K160415 · Instrumentation Laboratory CO · Chemistry

Dec 2016

Decision

306d

Days

Class 2

Risk

About This 510(k) Submission

K160415 is an FDA 510(k) clearance for the GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation), a Instrument, Hematocrit, Automated (Class II — Special Controls, product code GKF), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on December 14, 2016, 306 days after receiving the submission on February 12, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.5600.

Submission Details

510(k) Number	K160415 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 12, 2016
Decision Date	December 14, 2016
Days to Decision	306 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF