Helena Laboratories - FDA 510(k) Cleared Devices
280
Total
280
Cleared
0
Denied
132 devices
Cleared
Dec 15, 2010
SPECIALTY ASSAYED CONTROL-2
Hematology
336d
Cleared
Feb 23, 2007
PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA
Hematology
225d
Cleared
May 10, 2006
ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
Hematology
27d
Cleared
Jul 11, 2005
HEMORAM/AGGRAM ANALYZER
Hematology
182d
Cleared
Feb 14, 2003
PLATELETWORKS, MODELS PW-A, PW-C
Hematology
98d
Cleared
May 23, 2002
ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770
Hematology
63d
Cleared
Jan 10, 2002
ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752
Hematology
118d
Cleared
Sep 28, 2001
PLATELETWORKS
Hematology
44d
Cleared
Nov 27, 2000
COLOSCREEN-ES
Hematology
31d
Cleared
Sep 21, 1999
ACID HEMOGLOBIN KIT
Hematology
83d
Cleared
Dec 17, 1998
SPIFE ALKALINE HEMOGLOBIN
Hematology
157d
Cleared
May 12, 1998
COLOSCREEN-ES
Hematology
81d
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