NO PROPRIETARY NAME LISTED MANUFACTURED BY HELENA LABORATORIES

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Request for Information Form	Contact Information
Company Name	HELENA LABORATORIES
Address	1530 LINDBERGH DR.
City, State, Zip	BEAUMONT, TX 77704
Country	US
FDA Owner/Operator Phone	409-842-3714
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	JPC
FDA Classification Name	HEMOGLOBIN F QUANTITATION
FDA Device Classification Code	Standards
FDA Regulation Number	864.7455
FDA Common Generic Name	NO COMMON NAME LISTED
FDA Proprietary Device Name	NO PROPRIETARY NAME LISTED
FDA Owner / Operator Number	1618982
FDA Owner / Operator Name	HELENA LABORATORIES
FDA Establishment Registration Number	1618982
FDA Registered Establishment Name	HELENA LABORATORIES
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Our records indicate that the following medical device companyies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	JAS DIAGNOSTICS, INC. 7220 NW 58TH ST. MIAMI, FL 33166 US 305-418-2320 / 305-418-2320	HEMOGLOBIN CONTROL	HEMOGLOBIN CONTROL