Helena Laboratories - FDA 510(k) Cleared Devices
280
Total
280
Cleared
0
Denied
132 devices
Cleared
Jul 03, 1991
COLOSCREEN
Hematology
114d
Cleared
May 20, 1991
EPINEPHRINE REAGENT, CAT. NO. 5367
Hematology
94d
Cleared
May 20, 1991
COLLAGEN REAGENT CAT. NO. 5368
Hematology
89d
Cleared
May 20, 1991
ADP REAGENT
Hematology
84d
Cleared
Apr 16, 1991
HELENA THROMBOPLASTIN REAGENT WITH DILUENT
Hematology
110d
Cleared
Feb 27, 1991
HELENA THROMBOPLASTIN REAGENT, MODIFICATION
Hematology
75d
Cleared
Feb 11, 1991
AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183
Hematology
55d
Cleared
Jan 18, 1991
FREE PROTEIN S REAGENT CAT. NO. 5363
Hematology
126d
Cleared
Jun 15, 1990
COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581
Hematology
81d
Cleared
Jun 15, 1990
CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE
Hematology
39d
Cleared
May 25, 1990
CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 1430
Hematology
64d
Cleared
May 23, 1990
REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)
Hematology
72d
Cleared
Mar 23, 1990
TIP TOP(R) DISPENSER CAPS
Hematology
116d
Cleared
Mar 15, 1990
PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 5359
Hematology
141d
Cleared
Feb 05, 1990
PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357
Hematology
40d
Cleared
Jan 29, 1990
REP GLYCO CONTROL NORMAL(3209) AND ABNORMAL(3210)
Hematology
27d
Cleared
Jan 25, 1990
ROCKET REFERENCE PLASMA, CAT NO. 5188
Hematology
23d
Cleared
Jun 20, 1989
REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207
Hematology
54d
Cleared
Jun 07, 1989
HELENA THROMBOPLASTIN REAGENT
Hematology
70d
Cleared
Dec 27, 1988
LABILE LYSING REAGENT
Hematology
75d
Cleared
Sep 30, 1988
REP GLYCO SYSTEM
Hematology
150d
Cleared
Sep 30, 1988
HELENA COLOCARE
Hematology
86d
Cleared
Aug 25, 1988
OWREN'S VERONAL BUFFER
Hematology
9d
Cleared
May 06, 1988
TITAN GEL-PC GLYCO-HEME(TM) SYSTEM
Hematology
74d
Cleared
Apr 21, 1988
HBF DILUENT
Hematology
64d
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