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Radiometer America, Inc.

FDA 510(k) & PMA Approved Devices — 50 products

Total Devices50
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K153712 VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitJJY2016-01-28 View
510(k) K992859 ABL700 SERIES ANALYZER WITH AUTOCHECK MODULECHL2000-01-10 View
510(k) K991417 ABL 735 ANALYZERCHL1999-11-24 View
510(k) K982928 NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEMCHL1999-01-06 View
510(k) K980130 ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEMCHL1998-02-09 View
510(k) K980135 QUALICHECK5+ MODELS S7730, S7740, S7750, S7760JJS1998-01-28 View
510(k) K974818 ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEMMMI1998-01-16 View
510(k) K973367 ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEMCHL1997-10-06 View
510(k) K962158 PICO MODELS 30, 50, 70JKA1996-10-29 View
510(k) K962334 EML105 ELECTROLYTE METABOLITE ANALYZERJGS1996-10-24 View
510(k) K961355 MULTICHECKJJS1996-06-14 View
510(k) K961354 QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660)JJS1996-06-14 View
510(k) K952725 MULTICHECKGLY1996-02-20 View
510(k) K954612 ABL SYSTEM 625, 615, 605CHL1995-11-09 View
510(k) K952621 EML105 ELECTROLYTE METABOLITE ANALYZERCGA1995-10-17 View
510(k) K951240 JUSTONEJWY1995-10-07 View
510(k) K951241 HAEMOPHILUS/PNEUMOCOCCUS MIC PLATEJWY1995-10-07 View
510(k) K952637 QUALICHECK 4 GLUCOSEJJS1995-09-05 View
510(k) K936305 SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATESJWY1995-07-13 View
510(k) K943882 ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEMCHL1995-03-10 View
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