GLY · Class II · 21 CFR 864.7500

FDA Product Code GLY: Oximeter To Measure Hemoglobin

Leading manufacturers include Nova Biomedical Corp., Nir Diagnostics, Inc. and Avl Scientific Corp..

5
Total
5
Cleared
136d
Avg days
1989
Since

FDA 510(k) Cleared Oximeter To Measure Hemoglobin Devices (Product Code GLY)

5 devices
1–5 of 5
Cleared May 05, 2005
HEMONIR TM
K050014
Nir Diagnostics, Inc.
Hematology · 122d
Cleared Dec 02, 1999
STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR
K993104
Nova Biomedical Corp.
Hematology · 77d
Cleared Apr 25, 1996
NOVA CO-OXIMETER ANALYZER
K955013
Nova Biomedical Corp.
Hematology · 176d
Cleared Feb 20, 1996
MULTICHECK
K952725
Radiometer America, Inc.
Chemistry · 251d
Cleared Nov 06, 1989
AVL MODEL 912 CO-OXYLITE
K895466
Avl Scientific Corp.
Hematology · 56d

About Product Code GLY - Regulatory Context