Instrumentation Laboratory CO - FDA 510(k) Cleared Devices
321
Total
320
Cleared
1
Denied
126 devices
Cleared
Jun 18, 1993
IL MCL-2 COAGULATION ANALYZER
Hematology
309d
Cleared
Apr 12, 1993
IL TEST(TM) PROTEIN S
Hematology
80d
Cleared
Jan 14, 1993
IL TEST(TM) PRO-CHROM
Hematology
108d
Cleared
Oct 26, 1992
IL TEST PT FIBRINOGEN HS
Hematology
82d
Cleared
Aug 12, 1992
IL TEST(TM) ALPHA-2-ANTIPLASMIN ASSAY SYSTEM
Hematology
223d
Cleared
Oct 09, 1991
IL TEST PROCLOT ASSAY STYSTEM
Hematology
112d
Cleared
Sep 19, 1991
ACL COAGULATION SYSTEMS,MODELS 1000,2000,3000,PLUS
Hematology
129d
Cleared
Jun 27, 1988
ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS
Hematology
88d
Cleared
Feb 18, 1988
CELLECT MODEL D, AUTOMATED HEMTALOGY ANALYZER
Hematology
91d
Cleared
Jan 27, 1988
CELLECT LABTRAK SOFTWARE
Hematology
98d
Cleared
Jan 21, 1987
IL TEST 84668-15, FACTOR VIII CONTROL PLASMA
Hematology
69d
Cleared
Jan 05, 1987
IL TEST 97575-15, HEPARIN ASSAY
Hematology
69d
Cleared
Jan 05, 1987
COAGULATION INTRINSIC DEFICIENT PLASMAS
Hematology
53d
Cleared
Jan 05, 1987
COAGULATION EXTRINSIC DEFICIENT PLASMAS
Hematology
52d
Cleared
Dec 04, 1986
IL TEST 97573-15, PLASMINOGEN ASSAY
Hematology
37d
Cleared
Nov 25, 1986
IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAY
Hematology
28d
Cleared
Nov 25, 1986
IL TEST 97574-15M, ANTITTHROMBIN III ASSASY
Hematology
28d
Cleared
Nov 25, 1986
IL TEST 84673-30 CHROMOGENICS CONTROL PLASMA
Hematology
27d
Cleared
Sep 04, 1986
CELLECT 8E AUTOMATED BLOOD CELL COUNTERS
Hematology
72d
Cleared
Sep 04, 1986
IL CELLECT 7
Hematology
10d
Cleared
Sep 04, 1986
IL CELLECT 8
Hematology
10d
Cleared
Sep 03, 1986
IL SYSTEM 810, ACL AND THE REAGENT SETS
Hematology
78d
Cleared
Sep 06, 1984
IL TEST ANTITHROMBIN III ACTIVITY
Hematology
132d
Cleared
Apr 04, 1984
MANUAL BLOOD CELL COUNTING DEVICE
Hematology
23d
Cleared
Jan 26, 1982
IL 703, STAT SEPARATOR
Hematology
119d
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