Helena Laboratories is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Helena Laboratories - FDA 510(k) Cleared Devices
Recent clearances: V8 SP NORMAL CONTROL, ABNORMAL CONTROL, SPECIALTY ASSAYED CONTROL-2, PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA
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.
FDA 510(k) Regulatory Record - Helena Laboratories
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
Looking for a specific device from Helena Laboratories? Search by device name or K-number.
Search all Helena Laboratories devices