HEMATACHEK AND ULTRACHEK MANUFACTURED BY SEPARATION TECHNOLOGY, INC.

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Request for Information Form	Contact Information
Company Name	SEPARATION TECHNOLOGY, INC.
Address	1096 RAINER DR.
City, State, Zip	ALTAMONTE SPRINGS, FL 32714
Country	US
FDA Owner/Operator Phone	412-490-8425
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	GLK
FDA Classification Name	CONTROL, HEMATOCRIT
FDA Device Classification Code	Standards
FDA Regulation Number	864.8625
FDA Common Generic Name	HEMATOLOGY QUALITY CONTROL MIXTURE
FDA Proprietary Device Name	HEMATACHEK AND ULTRACHEK
FDA Owner / Operator Number	2517925
FDA Owner / Operator Name	FISHER SCIENTIFIC CO., LLC.
FDA Establishment Registration Number	1721649
FDA Registered Establishment Name	SEPARATION TECHNOLOGY, INC.
FDA Operation Code(s)	MS - Specification Developer
FDA Listing Date	06-19-06
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	AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE. CARLSBAD, CA 92008 US 760-431-7922 / 760-431-7922	AUDIT MICROTUBE MICROHEMATOCRIT	HEMATOCRIT CONTROLS
2	BIONOSTICS, INC. 7 JACKSON RD. DEVENS, MA 01434 US 978-772-7070 / 978-772-7070 220	MULTIPLE HEMATOCRIT CONTROLS	HEMATOCRIT CONTROLS
3	INSTRUMENTATION LABORATORY CO. 526 RT. 303 ORANGEBURG, NY 10962 US 781-861-4467 / 781-861-4467	MULTIPLE	HEMATOCRIT CONTROL
4	INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS 2 RESEARCH WAY PRINCETON, NJ 08540 US 781-674-3900 / 609-627-8038	STAT-CRIT	STAT-CRIT
5	NOVA BIOMEDICAL CORP. 200 PROSPECT ST. WALTHAM, MA 02454 US 781-894-0800 211 / 781-894-0800 211	HEMATOCRIT CONTROLS	HEMATOCRIT CONTROLS
6	RICHMOND DIAGNOSTICS, INC. 100 JERSEY AVE., SUITE 202-A, BLDG. B NEW BRUNSWICK, NJ 08901 US 732-246-2429 / 732-246-2429	HEMATACHEK	HEMATOCRIT CONTROL