Medical Device Manufacturer · US , Mchenry , IL

Helena Laboratories

280 submissions · 280 cleared · Since 1978
280
Total
280
Cleared
0
Denied

Helena Laboratories — FDA 510(k) Submissions

Helena Laboratories has submitted 280 FDA 510(k) premarket notifications since 1978, of which 280 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Assay, Glycosylated Hemoglobin, Test, Qualitative And Quantitative Factor Deficiency, Electrophoretic Separation, Lipoproteins, Electrophoretic, Protein Fractionation, Reagent, Occult Blood . Use the specialty filter in the sidebar to narrow results.

280 devices
1–25 of 280
V8 SP NORMAL CONTROL, ABNORMAL CONTROL
K131479 · JJY Multi-analyte Controls,... · Immunology
Oct 2013 138d
SPECIALTY ASSAYED CONTROL-2
K100103 · GGC Control, Plasma, Abnormal · Hematology
Dec 2010 336d
PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA
K061991 · GHR Reagent, Platelet... · Hematology
Feb 2007 225d
SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458
K061069 · CFF Immunoelectrophoretic,... · Immunology
Jul 2006 80d
ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
K061014 · JPA System, Multipurpose For... · Hematology
May 2006 27d
HEMORAM/AGGRAM ANALYZER
K050053 · JPA System, Multipurpose For... · Hematology
Jul 2005 182d
SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389
K024162 · CFF Immunoelectrophoretic,... · Immunology
Feb 2003 64d
PLATELETWORKS, MODELS PW-A, PW-C
K023761 · JOZ System, Automated... · Hematology
Feb 2003 98d
SPIFE CK KIT, MODEL 3332, 3333
K022757 · JHY Colorimetric Method, Cpk... · Chemistry
Oct 2002 52d
SPIFE LD-12 KIT, MODEL 3338
K022455 · CFE Electrophoretic, Lactate... · Chemistry
Oct 2002 67d
SPIFE LIPPOROTEIN-12, MODEL 3344
K022333 · JHO Electrophoretic... · Chemistry
Aug 2002 28d
ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770
K020914 · JBP Activated Whole Blood... · Hematology
May 2002 63d
SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346
K020625 · CIN Electrophoretic... · Chemistry
May 2002 69d
SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452
K020467 · CFE Electrophoretic, Lactate... · Chemistry
Mar 2002 45d
ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752
K013078 · JBP Activated Whole Blood... · Hematology
Jan 2002 118d
SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343
K013466 · JHO Electrophoretic... · Chemistry
Dec 2001 64d
PLATELETWORKS
K012723 · JOZ System, Automated... · Hematology
Sep 2001 44d
SPIFE IFE CALIBRATOR AND CONTROL KIT
K010617 · DEW Igg, Antigen, Antiserum,... · Immunology
Mar 2001 14d
COLOSCREEN-ES
K003359 · KHE Reagent, Occult Blood · Hematology
Nov 2000 31d
SPIFE CHOLESTEROL PROFILE KIT
K000603 · JHO Electrophoretic... · Chemistry
Apr 2000 54d
REP CHOLESTEROL PROFILE KIT
K992971 · JHO Electrophoretic... · Chemistry
Oct 1999 45d
ACID HEMOGLOBIN KIT
K992199 · JBD System, Analysis,... · Hematology
Sep 1999 83d
POLYSLIT IFE KIT
K990998 · CFF Immunoelectrophoretic,... · Immunology
Jun 1999 95d
SPIFE ALKALINE HEMOGLOBIN
K982426 · JBD System, Analysis,... · Hematology
Dec 1998 157d
SPIFE URINE IFE
K982639 · DAO Igm (mu Chain Specific),... · Immunology
Nov 1998 98d

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