Helena Laboratories - FDA 510(k) Cleared Devices
280
Total
280
Cleared
0
Denied
132 devices
Cleared
Aug 18, 1981
HELENA SICKLE-THAL QUIK COLUMN METHOD
Hematology
27d
Cleared
Mar 26, 1981
HELENA HEMOGLOBIN F CONTROLS
Hematology
31d
Cleared
Jan 09, 1981
HELENA HBA2 QUIK COLUMN METHOD
Hematology
30d
Cleared
Dec 30, 1980
HEMESPEC II
Hematology
32d
Cleared
Dec 30, 1980
HELENA HEMESPEC II TOTAL HEMOGLOBIN MET.
Hematology
32d
Cleared
Dec 22, 1980
HELENA AT-III QUIPLATE PROCEDURE
Hematology
34d
Cleared
Nov 12, 1980
AB-TROL COAGULATION CONTROL
Hematology
58d
Cleared
Oct 10, 1980
GLYCOSYLATED HEMOGLOBIN-SMC COLUMN
Hematology
25d
Cleared
Sep 26, 1980
HELENA GLYCOSYLATED HEMOGLOBIN QUIK METH
Hematology
164d
Cleared
Sep 09, 1980
HEP-TROL
Hematology
28d
Cleared
May 02, 1980
HELENA COLOCHECK
Hematology
65d
Cleared
May 02, 1980
HEMESPEC CHECK SET
Hematology
17d
Cleared
Apr 29, 1980
A,SA2 LYOPHILIZED HEMO CONTROL
Hematology
14d
Cleared
Apr 29, 1980
A,A2 LYOPHILIZED HEMO CONTROL
Hematology
14d
Cleared
Apr 29, 1980
A,FSC LYOPHILIZED HEMO CONTROL
Hematology
14d
Cleared
Apr 29, 1980
A,FDA2 LYOPHILIZED HEMO CONTROL
Hematology
14d
Cleared
Mar 25, 1980
HELENA RISTOCETIN
Hematology
27d
Cleared
Jan 24, 1980
HELENA COLOSCREEN
Hematology
29d
Cleared
Jan 24, 1980
HELENA FACTOR XII DEFICIENT
Hematology
29d
Cleared
Dec 31, 1979
HELENA FACTOR IX DEFICIENT SUBSTRATE
Hematology
28d
Cleared
Dec 31, 1979
HELENA FACTOR XI DEFICIENT SUBSTRATE
Hematology
28d
Cleared
Dec 31, 1979
HELENA FACTOR V DEFICIENT SUBSTRATE
Hematology
27d
Cleared
Dec 31, 1979
HELENA FACTOR X DEFICIENT SUBSTRATE
Hematology
27d
Cleared
Dec 31, 1979
HELENA FACTOR VII DEFICIENT SUB. PLASMA
Hematology
26d
Cleared
Dec 27, 1979
HELENA FACTOR II DEFICIENT SUB. PLASMA
Hematology
38d
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