Coulter Electronics, Inc. - FDA 510(k) Cleared Devices
101
Total
101
Cleared
0
Denied
51 devices
Cleared
Jul 30, 1985
COULTER CHANNELYZER 256
Hematology
96d
Cleared
Jan 07, 1985
COULTER MEAN PLATELET VOLUME CALIBRATOR
Hematology
96d
Cleared
Dec 17, 1984
COULTER CHECK SAMPLE UNASSAYED HEMATOLOG
Hematology
81d
Cleared
Dec 05, 1984
COULTER COUNTER MODEL M4
Hematology
104d
Cleared
Nov 13, 1984
COULTER COUNTER MODEL ZM
Hematology
92d
Cleared
Jul 27, 1984
COULTER AUTOMATIC SAMPLE HANDLER
Hematology
43d
Cleared
May 02, 1984
ASSIGNED VALUE FOR MEAN PLATELET
Hematology
40d
Cleared
Apr 04, 1984
S-CAL HEMATOLOGY CALIBRATOR
Hematology
41d
Cleared
Feb 21, 1984
COUNTER MODEL S880
Hematology
41d
Cleared
Feb 10, 1984
COULTER COUNTER M2
Hematology
43d
Cleared
Jan 10, 1984
COULTER COUNTER MODEL S-PLUS V
Hematology
90d
Cleared
Jan 03, 1984
HC PLUS
Hematology
83d
Cleared
Jun 16, 1983
E-Z PREP
Hematology
31d
Cleared
May 16, 1983
DIFF 4 SYSTEM
Hematology
95d
Cleared
Dec 28, 1982
COULTER-COUNTER #S PLUS IV & LYSE S +D
Hematology
49d
Cleared
Feb 04, 1982
HEMATOLOGY CALIBRATOR S-CAL
Hematology
65d
Cleared
Sep 17, 1980
LEUKOCYTE VOL. ANALYSIS APPARATUS
Hematology
6d
Cleared
Aug 14, 1980
MODIFIED BLOOD CELL COUNTING & LYSING
Hematology
66d
Cleared
Jan 29, 1980
COULTER COUNTER MODEL S PLUS
Hematology
50d
Cleared
Jan 29, 1980
COULTER COUNTER-BLOOD CELL COUNTER
Hematology
33d
Cleared
Nov 20, 1979
COUITER/CMS ISOTONIC BLOOD BANK SALINE
Hematology
32d
Cleared
Oct 30, 1979
COULTER DIFF3 SYS. (COULTER #7400003)
Hematology
35d
Cleared
Jan 03, 1979
BLOOD, HEMATOLOGY REFERENCE CONTROL
Hematology
40d
Cleared
Oct 27, 1978
HEMO-W SYSTEM
Hematology
32d
Cleared
Nov 28, 1977
HEMATOLOGY REFERENCE CONTROL
Hematology
73d