RADIOMETER AMERICA, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1523456	1523456	RADIOMETER AMERICA, INC.	1	Y	2026-01-01	6836 Engle Rd Middleburg Heights OH US 44130

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
40376	1226340699	K153712	VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit	JJY	2016-01-28
40376	1634438308

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
JJY	1	2016-01-28

PMA#

RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO
1986-02-21
RADIOMETER AMERICA, INC.
RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO
1985-02-22
RADIOMETER AMERICA, INC.
RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO
1984-03-01
RADIOMETER AMERICA, INC.
RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO
1981-09-21
RADIOMETER AMERICA, INC.

PMN#

ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE
2000-01-10
RADIOMETER AMERICA, INC.
ABL 735 ANALYZER
1999-11-24
RADIOMETER AMERICA, INC.
NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM
1999-01-06
RADIOMETER AMERICA, INC.
ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM
1998-02-09
RADIOMETER AMERICA, INC.
QUALICHECK5+ MODELS S7730, S7740, S7750, S7760
1998-01-28
RADIOMETER AMERICA, INC.
ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
1998-01-16
RADIOMETER AMERICA, INC.
ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
1997-10-06
RADIOMETER AMERICA, INC.
PICO MODELS 30, 50, 70
1996-10-29
RADIOMETER AMERICA, INC.
EML105 ELECTROLYTE METABOLITE ANALYZER
1996-10-24
RADIOMETER AMERICA, INC.
QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660)
1996-06-14
RADIOMETER AMERICA, INC.
MULTICHECK
1996-06-14
RADIOMETER AMERICA, INC.
MULTICHECK
1996-02-20
RADIOMETER AMERICA, INC.
ABL SYSTEM 625, 615, 605
1995-11-09
RADIOMETER AMERICA, INC.
EML105 ELECTROLYTE METABOLITE ANALYZER
1995-10-17
RADIOMETER AMERICA, INC.
JUSTONE
1995-10-07
RADIOMETER AMERICA, INC.
HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE
1995-10-07
RADIOMETER AMERICA, INC.
QUALICHECK 4 GLUCOSE
1995-09-05
RADIOMETER AMERICA, INC.
SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES
1995-07-13
RADIOMETER AMERICA, INC.
ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM
1995-03-10
RADIOMETER AMERICA, INC.
SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP
1995-02-24
RADIOMETER AMERICA, INC.
ABL5 BLOOD GAS SYSTEM
1994-05-27
RADIOMETER AMERICA, INC.
ABL SYSTEM 620
1994-05-27
RADIOMETER AMERICA, INC.
MULTICHECK(TM)
1994-04-26
RADIOMETER AMERICA, INC.
EML 100
1994-04-26
RADIOMETER AMERICA, INC.
SENSI-CAL AMCO AEPA-1
1994-03-29
RADIOMETER AMERICA, INC.
SENSITITRE SUSCEPTIBILITY PLATES
1993-03-09
RADIOMETER AMERICA, INC.
CALIBRATION VERIFICATION KIT OR CVK
1993-03-09
RADIOMETER AMERICA, INC.
MICROBACT SOLID PLATE SYSTEMS
1992-09-22
RADIOMETER AMERICA, INC.
ABL50 BLOOD GAS SYSTEM
1992-08-28
RADIOMETER AMERICA, INC.
MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM
1992-02-18
RADIOMETER AMERICA, INC.
ABL505 BLOOD GAS & ELECTROLYTE SYSTEM
1992-01-28
RADIOMETER AMERICA, INC.
QUALICHECK 4
1992-01-02
RADIOMETER AMERICA, INC.
ABL520 BLOOD GAS SYSTEM
1991-07-09
RADIOMETER AMERICA, INC.
ABL510 BLOOD GAS SYSTEM
1990-12-13
RADIOMETER AMERICA, INC.
QUALICHECK 3
1990-11-02
RADIOMETER AMERICA, INC.
E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT.
1990-04-16
RADIOMETER AMERICA, INC.
QS90 SMOOTH E ARTERIAL BLOOD SAMPLER
1990-01-23
RADIOMETER AMERICA, INC.
ABL500 BLOOD GAS SYSTEM
1989-10-06
RADIOMETER AMERICA, INC.
OXIMETER
1989-09-05
RADIOMETER AMERICA, INC.
SENSITITRE INDOLE REAGENT
1989-08-31
RADIOMETER AMERICA, INC.

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