Coulter Electronics, Inc. - FDA 510(k) Cleared Devices
101
Total
101
Cleared
0
Denied
101 devices
Cleared
Sep 19, 1988
COULTER VISCOMETER II
Chemistry
33d
Cleared
Aug 30, 1988
DART CARBON DIOXIDE
Chemistry
42d
Cleared
May 27, 1988
DART PHENYTOIN
Chemistry
123d
Cleared
Apr 04, 1988
COULTER VCS LEUKOCYTE DIFFERENTIAL COUNTER
Hematology
55d
Cleared
Mar 09, 1988
COULTER CLONE T11 MONOCLONAL ANTIBODY
Hematology
92d
Cleared
Feb 19, 1988
COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT.
Hematology
87d
Cleared
Jan 19, 1988
COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA
Hematology
97d
Cleared
Nov 04, 1987
DART (R) ELECTROLYTE REAGENT SYSTEM
Chemistry
21d
Cleared
Sep 16, 1987
COULTER DART CK-MB ISOENZYME REAGENT SYSTEM
Chemistry
112d
Cleared
Jul 02, 1987
COULTER COUNTER MODEL S-PLUS STKR
Hematology
51d
Cleared
May 20, 1987
S-CAL HEMATOLOGY CALIBRATOR
Hematology
351d
Cleared
Apr 14, 1987
DART THEOPHYLLINE REAGENT SYSTEM
Toxicology
48d
Cleared
Feb 12, 1987
DART DIGOXIN ASSAY
Chemistry
65d
Cleared
Feb 04, 1987
IMMUNO-SURE
Hematology
72d
Cleared
Jan 13, 1987
DART PHENOBARBITAL ASSAY SYSTEM
Toxicology
50d
Cleared
Sep 04, 1986
COULTER COUNTER MODEL T-890
Hematology
23d
Cleared
Sep 04, 1986
COULTER COUNTER MODEL T-540
Hematology
23d
Cleared
Aug 06, 1986
COULTER COUNTER MODEL S PLUS JUNIOR
Hematology
90d
Cleared
Aug 01, 1986
DART AMYLASE-D.S. REAGENT SYSTEM
Chemistry
38d
Cleared
Dec 30, 1985
DART CK-MB REAGENT SYSTEM
Chemistry
38d
Cleared
Nov 12, 1985
DART IRON & IRON BINDING CAPACITY REAGENT
Chemistry
18d
Cleared
Nov 05, 1985
COULTER COUNTER MODEL T-660
Hematology
28d
Cleared
Oct 10, 1985
COULTER COUNTER MODEL M5
Hematology
56d
Cleared
Aug 30, 1985
COULTER VOLUME ADAPTER
Hematology
119d
Cleared
Jul 30, 1985
COULTER CHANNELYZER 256
Hematology
96d
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