Gem Premier 4000 510(k) FDA Premarket Notification K112995 INSTRUMENTATION LABORATORY CO.

Device ID	K112995
510k Number	K112995
Device Name:	GEM PREMIER 4000
Classification	Electrode, Ion Specific, Potassium
Applicant	INSTRUMENTATION LABORATORY CO. 526 ROUTE 303 Orangeburg, NY 10962
Contact	Carl Marble
Correspondent	Carl Marble INSTRUMENTATION LABORATORY CO. 526 ROUTE 303 Orangeburg, NY 10962
Product Code	CEM
Subsequent Product Code	CGA
Subsequent Product Code	CGZ
Subsequent Product Code	CHL
Subsequent Product Code	CIG
Subsequent Product Code	GHS
Subsequent Product Code	GKF
Subsequent Product Code	GKR
Subsequent Product Code	GLK
Subsequent Product Code	GLY
Subsequent Product Code	JFP
Subsequent Product Code	JGS
Subsequent Product Code	JJY
Subsequent Product Code	KHP
Subsequent Product Code	MQM
CFR Regulation Number	862.1600 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Traditional
3rd Party Reviewed	No
Combination Product	No
Date Received	2011-10-07
Decision Date	2012-05-03
Summary:	summary

GEM PREMIER 4000