I-stat 1 Wireless Analyzer 510(k) FDA Premarket Notification K103195 ABBOTT POINT OF CARE INC.

Device ID	K103195
510k Number	K103195
Device Name:	I-STAT 1 WIRELESS ANALYZER
Classification	Glucose Oxidase, Glucose
Applicant	ABBOTT POINT OF CARE INC. 400 COLLEGE RD EAST Princeton, NJ 08540
Contact	Larry W Krasley
Correspondent	Larry W Krasley ABBOTT POINT OF CARE INC. 400 COLLEGE RD EAST Princeton, NJ 08540
Product Code	CGA
Subsequent Product Code	CDS
Subsequent Product Code	CEM
Subsequent Product Code	CGL
Subsequent Product Code	CGZ
Subsequent Product Code	CHL
Subsequent Product Code	GJS
Subsequent Product Code	JBP
Subsequent Product Code	JFL
Subsequent Product Code	JFP
Subsequent Product Code	JGS
Subsequent Product Code	JPI
Subsequent Product Code	KHP
Subsequent Product Code	MMI
Subsequent Product Code	MYT
Subsequent Product Code	NBC
CFR Regulation Number	862.1345 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Traditional
3rd Party Reviewed	No
Combination Product	No
Date Received	2010-10-29
Decision Date	2011-02-08
Summary:	summary

I-STAT 1 WIRELESS ANALYZER