Helena Laboratories - FDA 510(k) Cleared Devices
280
Total
280
Cleared
0
Denied
132 devices
Cleared
Oct 07, 1994
SPECIALTY ASSAYED CONTROL-1
Hematology
183d
Cleared
Sep 14, 1994
SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.)
Hematology
152d
Cleared
Apr 20, 1994
HELENA THROMBOPLASTIN-MI REAGENT
Hematology
86d
Cleared
Mar 22, 1994
COAGULATION A.R.P.
Hematology
264d
Cleared
Aug 23, 1993
CASCADE M, CAT. NO. 1710
Hematology
125d
Cleared
Aug 16, 1993
REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)
Hematology
144d
Cleared
Jul 06, 1993
REP ALKALINE HB-15 #3196,-8 #3197,-4 3198
Hematology
104d
Cleared
Feb 12, 1993
OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376
Hematology
64d
Cleared
Dec 18, 1992
SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479
Hematology
80d
Cleared
Aug 25, 1992
COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL
Hematology
49d
Cleared
Aug 25, 1992
COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL
Hematology
49d
Cleared
Aug 17, 1992
MODIFICATION COLUMNMATE
Hematology
186d
Cleared
Jul 10, 1992
COLUMNMATE II
Hematology
93d
Cleared
Jun 29, 1992
CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)
Hematology
94d
Cleared
Jun 09, 1992
GLYCO-TEK AFFINITY COLUMN KIT
Hematology
89d
Cleared
Jun 09, 1992
CASCADE 480
Hematology
81d
Cleared
May 01, 1992
THROMBIN CLOTTING TIME REAGENT
Hematology
109d
Cleared
Mar 04, 1992
COAGULATION ARPR,CAT.NO.5185
Hematology
121d
Cleared
Feb 14, 1992
ELLAGIC ACID APTT REAGENT
Hematology
74d
Cleared
Jan 13, 1992
CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION
Hematology
76d
Cleared
Dec 17, 1991
COLUMNMATE(TM) BETA-THAL CAT. NO. 4515
Hematology
141d
Cleared
Aug 22, 1991
ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED
Hematology
142d
Cleared
Aug 22, 1991
ARACHIDONIC ACID
Hematology
59d
Cleared
Aug 16, 1991
PACKS-4 (TM) ANALYZER
Hematology
88d
Cleared
Jul 03, 1991
COLOCARE
Hematology
226d
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