Helena Laboratories - FDA 510(k) Cleared Devices
280
Total
280
Cleared
0
Denied
132 devices
Cleared
Dec 04, 1979
NORM-TROL
Hematology
18d
Cleared
Dec 04, 1979
HELENA FACTOR VIII DEFICIENT SUB. PLASMA
Hematology
15d
Cleared
Jun 28, 1979
LYOPHILIZED G-HB QUIK COLUMN CONTROL
Hematology
10d
Cleared
May 31, 1979
COAGULATION ARP
Hematology
31d
Cleared
Apr 23, 1979
QUIK COLUMN METHODOLOGY
Hematology
27d
Cleared
Jan 26, 1979
G-HB QUIK COLUMN CONTROL
Hematology
21d
Cleared
Jun 02, 1978
HBF-QUIPLATE METHODOLOGY
Hematology
29d
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