Radiometer America Inc

FDA Filings

This page includes the latest FDA filings for Radiometer America Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Radiometer America Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• MATT ACKERMAN

FDA Registration(s)

• Registration Number: 1523456
• FEI Number: 1523456
• Name: RADIOMETER AMERICA, INC.
• Owner & Operator: RADIOMETER MEDICAL APS
• Contact Address: AAKANDEVEJ 21 --; BROENSHOEJ DK-84 Region Hovedstaden 2700 DK
• Official Correspondent:
  • Gitte J Friis
  • 45-21-693280-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 810 SHARON DR. ; WESTLAKE, OH 44145 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

• Registration Number: 3010420736
• FEI Number: 3010420736
• Name: Radiometer America, Inc
• Owner & Operator: RADIOMETER MEDICAL APS
• Contact Address: AAKANDEVEJ 21 --; BROENSHOEJ DK-84 Region Hovedstaden 2700 DK
• Official Correspondent:
  • Gitte J Friis
  • 45-21-693280-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 250 S Kraemer Blvd ; Brea, CA 92821 US

FDA Filings

Device Company	Device	Date
GUDID 10860003561925 RADIOMETER AMERICA INC.	Safe PICO Kit	2021-02-25
GUDID 10860003561901 RADIOMETER AMERICA INC.	Safe PICO Kit	2021-02-25
GUDID 01860003561927 RADIOMETER AMERICA INC.	safePICO	2020-10-05
GUDID 01860003561903 RADIOMETER AMERICA INC.	safePICO	2020-10-05
GUDID 00860003561966 RADIOMETER AMERICA INC.	VK-CREA	2020-10-05
GUDID 00860003561959 RADIOMETER AMERICA INC.	VKR-7	2020-10-05
GUDID 00860003561942 RADIOMETER AMERICA INC.	VKR-5	2020-10-05
GUDID 00860003561928 RADIOMETER AMERICA INC.	safePICO	2020-10-05
GUDID 00860003561904 RADIOMETER AMERICA INC.	Safe PICO Kit	2020-10-05
GUDID 00860003561935 RADIOMETER AMERICA INC.	VK-3	2020-10-01
PMN K153712 RADIOMETER AMERICA INC.	VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit	2016-01-28
PMN K992859 RADIOMETER AMERICA, INC.	ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE	2000-01-10
PMN K991417 RADIOMETER AMERICA, INC.	ABL 735 ANALYZER	1999-11-24
PMN K982928 RADIOMETER AMERICA, INC.	NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM	1999-01-06
PMN K980130 RADIOMETER AMERICA, INC.	ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM	1998-02-09
PMN K980135 RADIOMETER AMERICA, INC.	QUALICHECK5+ MODELS S7730, S7740, S7750, S7760	1998-01-28
PMN K974818 RADIOMETER AMERICA, INC.	ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM	1998-01-16
PMN K973367 RADIOMETER AMERICA, INC.	ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM	1997-10-06
PMN K962158 RADIOMETER AMERICA, INC.	PICO MODELS 30, 50, 70	1996-10-29
PMN K962334 RADIOMETER AMERICA, INC.	EML105 ELECTROLYTE METABOLITE ANALYZER	1996-10-24
PMN K961355 RADIOMETER AMERICA, INC.	MULTICHECK	1996-06-14
PMN K961354 RADIOMETER AMERICA, INC.	QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660)	1996-06-14
PMN K952725 RADIOMETER AMERICA, INC.	MULTICHECK	1996-02-20
PMN K954612 RADIOMETER AMERICA, INC.	ABL SYSTEM 625, 615, 605	1995-11-09
PMN K952621 RADIOMETER AMERICA, INC.	EML105 ELECTROLYTE METABOLITE ANALYZER	1995-10-17
PMN K951241 RADIOMETER AMERICA, INC.	HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE	1995-10-07
PMN K951240 RADIOMETER AMERICA, INC.	JUSTONE	1995-10-07
PMN K952637 RADIOMETER AMERICA, INC.	QUALICHECK 4 GLUCOSE	1995-09-05
PMN K936305 RADIOMETER AMERICA, INC.	SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES	1995-07-13
PMN K943882 RADIOMETER AMERICA, INC.	ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM	1995-03-10
PMN K944753 RADIOMETER AMERICA, INC.	SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP	1995-02-24
PMN K935655 RADIOMETER AMERICA, INC.	ABL5 BLOOD GAS SYSTEM	1994-05-27
PMN K935121 RADIOMETER AMERICA, INC.	ABL SYSTEM 620	1994-05-27
PMN K935515 RADIOMETER AMERICA, INC.	MULTICHECK(TM)	1994-04-26
PMN K935120 RADIOMETER AMERICA, INC.	EML 100	1994-04-26
PMN K935566 RADIOMETER AMERICA, INC.	SENSI-CAL AMCO AEPA-1	1994-03-29
PMN K924802 RADIOMETER AMERICA, INC.	CALIBRATION VERIFICATION KIT OR CVK	1993-03-09
PMN K923045 RADIOMETER AMERICA, INC.	SENSITITRE SUSCEPTIBILITY PLATES	1993-03-09
PMN K923342 RADIOMETER AMERICA, INC.	MICROBACT SOLID PLATE SYSTEMS	1992-09-22
PMN K922922 RADIOMETER AMERICA, INC.	ABL50 BLOOD GAS SYSTEM	1992-08-28
PMN K912444 RADIOMETER AMERICA, INC.	MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM	1992-02-18
PMN K914166 RADIOMETER AMERICA, INC.	ABL505 BLOOD GAS & ELECTROLYTE SYSTEM	1992-01-28
PMN K915399 RADIOMETER AMERICA, INC.	QUALICHECK 4	1992-01-02
PMN K910827 RADIOMETER AMERICA, INC.	ABL520 BLOOD GAS SYSTEM	1991-07-09
PMN K904513 RADIOMETER AMERICA, INC.	ABL510 BLOOD GAS SYSTEM	1990-12-13
PMN K904733 RADIOMETER AMERICA, INC.	QUALICHECK 3	1990-11-02
PMN K900333 RADIOMETER AMERICA, INC.	E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT.	1990-04-16
PMN K896514 RADIOMETER AMERICA, INC.	QS90 SMOOTH E ARTERIAL BLOOD SAMPLER	1990-01-23
PMN K895181 RADIOMETER AMERICA, INC.	ABL500 BLOOD GAS SYSTEM	1989-10-06
PMN K893587 RADIOMETER AMERICA, INC.	OXIMETER	1989-09-05
PMN K894776 RADIOMETER AMERICA, INC.	SENSITITRE INDOLE REAGENT	1989-08-31
PMN K894110 RADIOMETER AMERICA, INC.	QUALICHECK 2	1989-08-03
PMN K890057 RADIOMETER AMERICA, INC.	SENSITITRE AUTO ID PLATE AP80	1989-06-09
PMN K871353 RADIOMETER AMERICA, INC.	OXIMETER	1987-06-08
CBT RADIOMETER AMERICA, INC. [RADIOMETER MEDICAL APS]	SAFEPICO	1986-04-28
CBT RADIOMETER AMERICA, INC. [RADIOMETER MEDICAL APS]	PICO	1986-04-28
PMN K860057 RADIOMETER AMERICA, INC.	ABL330 ACID BASE LABORATORY	1986-03-05
PMA P800043S004 RADIOMETER AMERICA, INC.	RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO	1986-02-21
PMN K853990 RADIOMETER AMERICA, INC.	OSM3 HEMOXIMETER	1985-12-30
PMA P800043S003 RADIOMETER AMERICA, INC.	RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO	1985-02-22
PMN K844295 RADIOMETER AMERICA, INC.	ABL300 ACID BASE LABORATORY	1984-12-10
PMA P800043S002 RADIOMETER AMERICA, INC.	RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO	1984-03-01
PMN K833696 RADIOMETER AMERICA, INC.	ACID BASE LABORATORY ABL4	1984-01-18
PMN K831034 RADIOMETER AMERICA, INC.	QUALISTICK ARTERIAL BLOOD SAMPLER	1983-05-18
PMN K830805 RADIOMETER AMERICA, INC.	KNAI SODIUM POTASSIUM ANALYZER	1983-04-08
PMA P800043S001 RADIOMETER AMERICA, INC.	RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO	1981-09-21

Related Finance Registrations

NCAGE Code	02AW2	RADIOMETER AMERICA INC
NCAGE Code	53727	RADIOMETER AMERICA INC.
NCAGE Code	6W934	RADIOMETER AMERICA INC
CAGE Code	02AW2	RADIOMETER AMERICA INC
CAGE Code	53727	RADIOMETER AMERICA INC.
CAGE Code	6W934	RADIOMETER AMERICA INC
S.A.M. Registration	53727 [86661485]	RADIOMETER AMERICA INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092431390	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL MEASUREMENT ACCESSORIE	23 PKG
2020092329931	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL MEASUREMENT ACCESSORIE	23 PKG
2020092139898	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL MEASUREMENT ACCESSORIE	23 PKG
2020091555111	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL MEASUREMENT ACCESSORIE	23 PKG
2020091253606	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL MEASUREMENT ACCESSORIE	23 PKG
2020091186137	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL MEASUREMENT ACCESSORIE	23 PKG
2020091033422	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL MEASURING EQUIPMENT	23 PKG
20200909123311	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL MEASUREMENT ACCESSORIE	23 PKG