Instrumentation Laboratory CO - FDA 510(k) Cleared Devices
Recent clearances: ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM, HemosIL Liquid Anti-Xa, GEM Premier ChemSTAT
321
Total
320
Cleared
1
Denied
FDA 510(k) Regulatory Record - Instrumentation Laboratory CO Cardiovascular ✕
13 devices
Cleared
Feb 04, 1984
IL HEPARINIZED FLOW DIRECTED THERMAL
Cardiovascular
81d
Cleared
Dec 22, 1982
THERMAL DILUTION CATHETER
Cardiovascular
29d
Cleared
Nov 01, 1982
IL 801 THERMALDILUTION CARDIAC OUTPUT
Cardiovascular
24d
Cleared
Apr 21, 1982
IL 7F FLOW DIRECTOR THERMAL DILU. CATH
Cardiovascular
37d
Cleared
Dec 15, 1978
CARDIAC CARE Q/C TEST KIT
Cardiovascular
9d
Cleared
Aug 23, 1978
DILUTION KIT, THERMAL, COLD PAC
Cardiovascular
37d
Cleared
Jan 03, 1978
CARDIAC OUTPUT COMPUTER MODEL 701
Cardiovascular
78d
Cleared
Jul 05, 1977
RECORD, MODEL 702, I.L.
Cardiovascular
43d
Cleared
Aug 27, 1976
SYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECT
Cardiovascular
11d
Cleared
Jul 21, 1976
CATHETER, THERMAL DILUTION, ANIMAL & PED
Cardiovascular
35d
Cleared
Jul 21, 1976
CATHETER, THERMAL DILUTION, PEDIATRIC
Cardiovascular
35d
Cleared
Jul 21, 1976
TRAY, ICED INJECTABLE (26420)
Cardiovascular
35d
Cleared
Jul 21, 1976
CATHETER, THERMAL DILUTION, OPEN CHEST
Cardiovascular
35d