Helena Laboratories - FDA 510(k) Cleared Devices
280
Total
280
Cleared
0
Denied
Helena Laboratories has 280 FDA 510(k) cleared medical devices. Based in Mchenry, US.
Historical record: 280 cleared submissions from 1978 to 2013. Primary specialty: Hematology.
Browse the FDA 510(k) cleared devices submitted by Helena Laboratories Filter by specialty or product code using the sidebar.
280 devices
Cleared
Oct 07, 2013
V8 SP NORMAL CONTROL, ABNORMAL CONTROL
Immunology
138d
Cleared
Dec 15, 2010
SPECIALTY ASSAYED CONTROL-2
Hematology
336d
Cleared
Feb 23, 2007
PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA
Hematology
225d
Cleared
Jul 06, 2006
SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL...
Immunology
80d
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 19, 2003
SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389
Immunology
64d
Cleared
Feb 14, 2003
PLATELETWORKS, MODELS PW-A, PW-C
Hematology
98d
Cleared
Oct 11, 2002
SPIFE CK KIT, MODEL 3332, 3333
Chemistry
52d
Cleared
Oct 01, 2002
SPIFE LD-12 KIT, MODEL 3338
Chemistry
67d
Cleared
Aug 15, 2002
SPIFE LIPPOROTEIN-12, MODEL 3344
Chemistry
28d
Cleared
May 23, 2002
ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770
Hematology
63d
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