HEMOCUE HEMOGLOBIN PHOTOMETER MANUFACTURED BY HEMOCUE AB

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Request for Information Form	Contact Information
Company Name	HEMOCUE AB
Address	KUVETTGATAN 1
City, State, Zip	ANGELHOLM,
Country	SW
FDA Owner/Operator Phone	464-314-5 82 00
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	GIG
FDA Classification Name	HEMOGLOBINOMETER
FDA Device Classification Code	Standards
FDA Regulation Number	864.7500
FDA Common Generic Name	HEMOGLOBINOMETER
FDA Proprietary Device Name	HEMOCUE HEMOGLOBIN PHOTOMETER
FDA Owner / Operator Number	9099323
FDA Owner / Operator Name	HEMOCUE AB
FDA Establishment Registration Number	3003044483
FDA Registered Establishment Name	HEMOCUE AB
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	12-06-00
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 companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 SOLON, OH 44139 US 440-349-1199 / 440-914-3409	AMRESCO CALCIUM REAGENT	CALCIUN REAGENT
2	PORTABLE MEDICAL LABORATORIES, INC. 544 SOUTH NARDO AVE. SOLANA BEACH, CA 92075 US 858-755-7385 / 858-755-7385	ANEMIA BOTTLE	HEMOGLOBIN SCREENING DEVICE
3	RANDOX LABORATORIES LIMITED 44 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4BN UK 44-28-90 422413 / 44-28-90422413	RANDOX BILIRUBIN	BILIRUBIN
4	RANDOX LABORATORIES LIMITED 36 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4RW UK 44-28-90 422413 / 44-28-90422413	RANDOX BILIRUBIN	BILIRUBIN