CHL · Class II · 21 CFR 862.1120

FDA Product Code CHL: Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

Leading manufacturers include Nova Biomedical Corp., Instrumentation Laboratory CO and Radiometer America, Inc..

188
Total
188
Cleared
103d
Avg days
1976
Since
188 devices
49–72 of 188
Cleared Jul 25, 2002
STAT PROFILE PHOX PLUS C ANALYZER
K021713
Nova Biomedical Corp.
Chemistry · 63d
Cleared Jul 16, 2002
EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER
K021515
Medica Corp.
Chemistry · 67d
Cleared Jun 10, 2002
STAT PROFILE CRITICAL CARE XPRESS ANALYZER
K020297
Nova Biomedical Corp.
Chemistry · 133d
Cleared Feb 28, 2002
STAT PROFILE PHOX ANALYZER
K014295
Nova Biomedical Corp.
Chemistry · 62d
Cleared Jan 15, 2002
STAT PROFILE PHOX BASIC ANALYZER
K013729
Nova Biomedical Corp.
Chemistry · 67d
Cleared Aug 20, 2001
STAT PROFILE PHOX PLUS L ANALYZER
K012058
Nova Biomedical Corp.
Chemistry · 49d
Cleared Dec 19, 2000
BAYER RAPIDPOINT 400 SYSTEM
K002738
Bayer Corp.
Chemistry · 109d
Cleared Oct 19, 2000
MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER
K002613
Nova Biomedical Corp.
Chemistry · 58d
Cleared Mar 20, 2000
AVL OPTI R ANALYZER
K000103
Avl Scientific Corp.
Chemistry · 67d
Cleared Feb 01, 2000
ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
K994346
Sendx Medical, Inc.
Chemistry · 40d
Cleared Jan 10, 2000
ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE
K992859
Radiometer America, Inc.
Chemistry · 138d
Cleared Jan 10, 2000
CLINICAL BLOOD GAS MIXTURE
K993789
General Air Service and Supply
Chemistry · 62d
Cleared Nov 24, 1999
ABL 735 ANALYZER
K991417
Radiometer America, Inc.
Chemistry · 215d
Cleared Nov 24, 1999
GEM PREMIER 3000
K992834
Instrumentation Laboratory CO
Chemistry · 93d
Cleared Jan 29, 1999
AVL OMNI MODULAR ANALYZER
K990092
Avl Scientific Corp.
Chemistry · 18d
Cleared Jan 06, 1999
NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM
K982928
Radiometer America, Inc.
Chemistry · 139d
Cleared Dec 23, 1998
6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497
K984384
Thermo Bioanalysis Corp.
Chemistry · 15d
Cleared Jul 22, 1998
MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)
K982277
Nova Biomedical Corp.
Chemistry · 23d
Cleared Apr 15, 1998
NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER
K980991
Nova Biomedical Corp.
Chemistry · 29d
Cleared Mar 19, 1998
IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE
K980523
Diametrics Medical, Inc.
Chemistry · 37d
Cleared Feb 09, 1998
ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM
K980130
Radiometer America, Inc.
Chemistry · 26d
Cleared Feb 05, 1998
EASYBLOOD GAS ANALYZER
K974526
Medica Corp.
Chemistry · 65d
Cleared Dec 18, 1997
IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE
K974396
Diametrics Medical, Inc.
Hematology · 27d
Cleared Oct 06, 1997
ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
K973367
Radiometer America, Inc.
Chemistry · 28d