Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1644474

FEI Number

1000116989

Entity Name

HELENA LABORATORIES, CORP.

City/State/Country

BEAUMONT, TX, US

Establishment Address

3795 WASHINGTON BLVD., BEAUMONT, TX 77705, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

HELENA LABORATORIES, CORP. (Owner Number: 1618982)

Owner / Operator Contact Address

1530 LINDBERGH DRIVE, Beaumont, TX 77707, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Actalyke XL Analyzer QuickScan Touch QuickScan 2000 QuickScan Touch PLUS Cascade POC Electronic QC Card Cascade POC Analyzer Cascade EQC Renew Sleeve SPIFE Serum Protein SPIFE 4000 SPIFE 3000 SPIFE Touch QuickGel SPE Vis SPIFE Nexus Amido Black Protein Stain 35uL Micropipette QuickGel Applicator Kit Super Z 12-Applicator Super Z Applicator Kit Super Z Sample Well Plates QuickGel Applicator Base ESH Touch Electrophoresis Sample Handler Super Z-12 Applicator Kit Super Z-12 Sample Well Plates Super Z Applicator QuickGel Applicator Super Z Aligning Base SPIFE 4000 IFE Antisera Pipette Tips Titan Plus Power Supply 10-100 µLVariable Volume Pipette with Tip Ejector H-Pette Remover Zip Zone Applicator QuickGel Modified Applicator Blades Bufferizer Zip Zone Aligning Base Cascade M-4 Cuvettes SPIFE IFE Sample Cups QuickGel Dispo Sample Cups - Shallow Well Zip Zone Prep Actalyke Thermometer SPIFE Urine/CSF Protein Accessories TITAN GEL Chamber Cooling Block SPIFE Dispo Sample Cups - Deep Well SPIFE Urine IFE Accessories SPIFE 4000 IFE Sample Trays REP Prep Solution Pipette Tips 1-200 µL SPIFE IFE-3/6 Urine Accessory Kit SPIFE Applicator Blades SPIFE Modified Applicator Blades Helena Electronic Clotting Tube SPIFE 4000 White Sample Trays SPIFE IFE-6 Rigid Antisera Template Blotter Pads, 76 x 102 mm QuickGel Gel Block Remover SPIFE IFE-3/6 Dispo Cup Tray Blotter Pads, 89 x 108 mm SPIFE Rigid Antisera Template-15 SPIFE Antisera Tray for IFE-6 & IFE-3 Titan Plastic Envelopes, 115 x 102 mm Super Z Micro Replacement Tips Serrated Blade Applicator Kit, 18 Sample (30) Cascade POC Power Supply Serrated Blade Applicator Kit, 20 Sample (10) SPIFE Nexus Applicator Blade Weights SPIFE Nexus Contact Sheets SPIFE Nexus Cassettes SPIFE Nexus Ready Run Kit SPIFE Nexus Carbon Electrode Insert SPIFE Nexus Dispo Stain Cups SPIFE Nexus Antisera Spreader Tips Serrated Blade Applicator Kit, 20 Sample (30) Serrated Blade Applicator Kit, 20 Sample (20) SPIFE Nexus Applicator Templates Serrated Blade Applicator Kit, 12 Sample (30) Serrated Blade Applicator Kit, 20 Sample (50) SPIFE Nexus Reagent Roller Super CK Aligning Base QuickGel IFE Applicator Blades SPIFE 4000 Maintenance Blotters Development Weight QuickGel Applicator Blades Tips for IFE-6/3 Multi-Channel Pipette Blade Applicator Kit, SPIFE 4000 IFE QuickGel Dispo Sample Cups - Deep Well SPIFE Dispo Sample Cups - Shallow Well Tips for IFE-9 Multi-Channel Pipette Titan III Cellulose Acetate Carrying Rack Zip Zone Sample Well Plate Siliconized Cuvettes for AggRAM Tips for IFE-15 Multi-Channel Pipette Electra B1 Buffer 1000 Staining Set Zip Zone Chamber Wicks Actalyke Mini II Analyzer Cascade M Cascade M-4 Optical Density Step Tablet DZA Replacement Lamp for REP Neutral Density Densitometer Control SPIFE 4000 Neutral Density Densitometer Control SPIFE Nexus Neutral Density Densitometer Control for QuickScan Cascade Abrazo Electronic QC Card (EQC) Cascade Abrazo Analyzer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JBP	Activated Whole Blood Clotting Time	Hematology	Class 2	864.7140	2008-01-14
JQT	Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica	Clinical Chemistry	Class 1	862.2400	2001-11-09
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2008-04-15
CEF	Electrophoretic, Protein Fractionation	Clinical Chemistry	Class 1	862.1630	1987-07-23
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2001-11-09
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2012-10-25
JBP	Activated Whole Blood Clotting Time	Hematology	Class 2	864.7140	2008-01-14
GKP	Instrument, Coagulation, Automated	Hematology	Class 2	864.5400	2007-11-19
JQJ	Densitometeric, Protein Fractionation	Clinical Chemistry	Class 1	862.1630	2012-10-25
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2014-05-28

Official Correspondent

Rachel Easley

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HELENA LABORATORIES, CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2916657	LABCON, NORTH AMERICA	PETALUMA, CA, US
1618982	HELENA LABORATORIES, CORP.	BEAUMONT, TX, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K915332	Ciba Corning Diagnostics Corp.	MODEL 795 FLUOROMETER/DENSITOMETER	1992-02-18
K924453	Organon Teknika Corp.	MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)	1992-12-18
K851403	Ventrex Laboratories, Inc.	VENTREZYME ALLERGEN DATA REDUCTION SYSTEM	1985-06-21
K761290	Nuclear Medical Laboratories, Inc.	COMPU-PET 300	1977-02-24
K770210	G.D. Searle and Co.	ANALYTIX AUTO SAMPLE PREP. STA. 1600	1977-02-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-06	BIOMERIEUX, INC.	2	VeriCal Calibrator Set
Z-0042-05	Dade Behring Inc. Rte 896, Glasgow Business Community	2	DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.
Z-0043-05	bioMerieux	2	The MDA system with MDA Antithrombin III MDA Heparin
Z-0736-04	Instrumentation Laboratory Co.	2	ACL Futura Instrument Analyzer
Z-0737-04	Instrumentation Laboratory Co.	2	ACL Advance Instrument Analyzer

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1644474. Last updated year: 2026. Please use registration number 1644474 when referencing this establishment in official correspondence.