Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Helena Laboratories

FDA 510(k) & PMA Approved Devices — 280 products

Total Devices280
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K131479 V8 SP NORMAL CONTROL, ABNORMAL CONTROLJJY2013-10-07 View
510(k) K100103 SPECIALTY ASSAYED CONTROL-2GGC2010-12-15 View
510(k) K061991 PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAGHR2007-02-23 View
510(k) K061069 SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458CFF2006-07-06 View
510(k) K061014 ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LPJPA2006-05-10 View
510(k) K050053 HEMORAM/AGGRAM ANALYZERJPA2005-07-11 View
510(k) K024162 SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389CFF2003-02-19 View
510(k) K023761 PLATELETWORKS, MODELS PW-A, PW-CJOZ2003-02-14 View
510(k) K022757 SPIFE CK KIT, MODEL 3332, 3333JHY2002-10-11 View
510(k) K022455 SPIFE LD-12 KIT, MODEL 3338CFE2002-10-01 View
510(k) K022333 SPIFE LIPPOROTEIN-12, MODEL 3344JHO2002-08-15 View
510(k) K020914 ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770JBP2002-05-23 View
510(k) K020625 SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346CIN2002-05-06 View
510(k) K020467 SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452CFE2002-03-29 View
510(k) K013078 ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752JBP2002-01-10 View
510(k) K013466 SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343JHO2001-12-21 View
510(k) K012723 PLATELETWORKSJOZ2001-09-28 View
510(k) K010617 SPIFE IFE CALIBRATOR AND CONTROL KITDEW2001-03-15 View
510(k) K003359 COLOSCREEN-ESKHE2000-11-27 View
510(k) K000603 SPIFE CHOLESTEROL PROFILE KITJHO2000-04-17 View
↑