Coulter Electronics, Inc. - FDA 510(k) Cleared Devices
101
Total
101
Cleared
0
Denied
101 devices
Cleared
Jan 29, 1980
COULTER COUNTER-BLOOD CELL COUNTER
Hematology
33d
Cleared
Dec 06, 1979
COULTER HDL CHOLESTEROL REAG. SYSTEM
Chemistry
17d
Cleared
Nov 20, 1979
COUITER/CMS ISOTONIC BLOOD BANK SALINE
Hematology
32d
Cleared
Oct 30, 1979
COULTER DIFF3 SYS. (COULTER #7400003)
Hematology
35d
Cleared
Sep 24, 1979
COULTER ACCU-ZYME II ENZYMATIC REAGENT
Chemistry
34d
Cleared
Jun 28, 1979
COULTER ACCU-ZYME IIY-GT REAGENT KIT
Chemistry
63d
Cleared
May 03, 1979
COULTER ACCU-ZYME II GOT REAGENT
Chemistry
55d
Cleared
May 01, 1979
COULTER ACCU-ZYME II GPT REAGENT
Chemistry
53d
Cleared
Jan 03, 1979
BLOOD, HEMATOLOGY REFERENCE CONTROL
Hematology
40d
Cleared
Oct 27, 1978
HEMO-W SYSTEM
Hematology
32d
Cleared
Oct 03, 1978
MINI-KEM
Toxicology
18d
Cleared
Sep 27, 1978
COULTER ELECTROLYTE ANALYZER SYSTEM
Chemistry
22d
Cleared
Aug 21, 1978
BUN (UREASE) REAGENT
Chemistry
31d
Cleared
Jul 28, 1978
ENZYMATIC REAGENT FOR CHOLESTEROL MEAS
Chemistry
42d
Cleared
Apr 24, 1978
THYRO-ZYME-T4 ASSAY KIT
Chemistry
42d
Cleared
Nov 28, 1977
HEMATOLOGY REFERENCE CONTROL
Hematology
73d
Cleared
Nov 09, 1977
COUNTER MODEL S PLUS BLOOD CELL COUNTER
Chemistry
93d
Cleared
Aug 22, 1977
KEM-O-MAT
Chemistry
14d
Cleared
Jun 17, 1977
REAGENT, CHLORIDE, COULTER
Chemistry
53d
Cleared
May 03, 1977
CHEMISTRY, COULTER
Chemistry
22d
Cleared
Oct 08, 1976
4C ABNORMAL LOW-HIGH (8 X 6 M1)
Hematology
18d
Cleared
Aug 03, 1976
NDC#12739-0011-1 C-ZYME GOT
Chemistry
28d
Cleared
Aug 03, 1976
NDC#12739-0010-1 C-ZYME GPT
Chemistry
28d
Cleared
Aug 03, 1976
REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1
Chemistry
28d
Cleared
Aug 03, 1976
ASSAY, AMPHET. NDC#11711-0127-1 COULTER
Toxicology
28d
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