Helena Laboratories - FDA 510(k) Cleared Devices
280
Total
280
Cleared
0
Denied
132 devices
Cleared
Feb 19, 1988
FACTOR VIII REFERENCE PLASMA
Hematology
25d
Cleared
Nov 20, 1987
CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA
Hematology
88d
Cleared
Jul 09, 1987
CHROM-TROL
Hematology
20d
Cleared
Jun 10, 1987
Q.I.C. BLEEDING TIME DEVICE
Hematology
68d
Cleared
Jul 23, 1985
MONITOR IV PLUS
Hematology
91d
Cleared
Dec 05, 1984
COLOSCREEN SELF-TEST
Hematology
100d
Cleared
Oct 15, 1984
GLYCO-TEK AFFINITY COLUMN
Hematology
97d
Cleared
Aug 10, 1984
HELENA COLOSCREEN SELF-TEST
Hematology
164d
Cleared
May 02, 1984
FIBRINOGEN ASSAY KIT
Hematology
51d
Cleared
May 01, 1984
BIOSURE
Hematology
67d
Cleared
Apr 05, 1984
RISTOCETIN COFACTOR ASSAY
Hematology
71d
Cleared
Dec 16, 1983
FACTOR II DEFICIENT SUBSTRATE PLASMA
Hematology
24d
Cleared
Nov 03, 1983
GLYCO-JE,E CPMTRP
Hematology
36d
Cleared
Oct 20, 1983
PLATELET AGGREGATION REAGENT SET
Hematology
90d
Cleared
Aug 24, 1983
TITAN GEL GLYCO-HEME SYSTEM
Hematology
57d
Cleared
Apr 05, 1983
ACTIVAT-PARTIAL THROMBO-PLASTIN
Hematology
64d
Cleared
Apr 05, 1983
LIQUID THROMBOPLASTIN REAGENT
Hematology
63d
Cleared
Feb 01, 1983
GLYCO HB QUIK COLUMN PROCEDURE
Hematology
40d
Cleared
Feb 01, 1983
BETA THALQUIK COLUMN #5341
Hematology
40d
Cleared
Dec 28, 1982
FACTOR VIII RELATED ANTIGEN ROCKET EID
Hematology
56d
Cleared
Aug 05, 1982
ISOPROPANOL HEMOGLOBIN STABILITY TEST
Hematology
17d
Cleared
Apr 08, 1982
HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL
Hematology
16d
Cleared
Apr 01, 1982
HELENA HEMOGLOBIN DETECT COLUMN SYS
Hematology
30d
Cleared
Oct 23, 1981
HELENA COLOSCREEN METHOD
Hematology
59d
Cleared
Sep 01, 1981
HELENA HBF QUIPLATE CONTROL
Hematology
22d
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