MULTIPLE: SYNTHESIS, GEM PREMIER 3000, ETC. MANUFACTURED BY INSTRUMENTATION LABORATORY CO.

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Request for Information Form	Contact Information
Company Name	INSTRUMENTATION LABORATORY CO.
Address	113 HARTWELL AVE.
City, State, Zip	LEXINGTON, MA 02421
Country	US
FDA Owner/Operator Phone	781-861-4467
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	GKF
FDA Classification Name	INSTRUMENT, HEMATOCRIT, AUTOMATED
FDA Device Classification Code	Standards
FDA Regulation Number	864.5600
FDA Common Generic Name	HEMATOCRIT TEST SYSTEM
FDA Proprietary Device Name	MULTIPLE: SYNTHESIS, GEM PREMIER 3000, ETC.
FDA Owner / Operator Number	1217183
FDA Owner / Operator Name	INSTRUMENTATION LABORATORY CO.
FDA Establishment Registration Number	1217183
FDA Registered Establishment Name	INSTRUMENTATION LABORATORY CO.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	07-13-00
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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1	INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS 2 RESEARCH WAY PRINCETON, NJ 08540 US 781-674-3900 / 609-627-8038	STAT--CRIT	STAT--CRIT
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5	SENDX MEDICAL, INC. 1945 PALOMAR OAKS WAY CARLSBAD, CA 92011 US 45-38-273827 / 45-38-273617	MULTIPLE	VARIOUS DODELS OF BLOOD ANALYZERS
6	SEPARATION TECHNOLOGY, INC. 1096 RAINER DR. ALTAMONTE SPRINGS, FL 32714 US 412-490-8425 / 412-490-8425	ULTRACRIT HEMATOCRIT MEASUREMENT DEVICE	AUTOMATED HEMATOCRIT INSTRUMENT
7	SORIN GROUP USA, INC. 14401 WEST 65TH WAY ARVADA, CO 80004 US 303-467-6306 / 303-467-6306	SATURATION-HEMATOCRIT MONITOR	HEMATOCRIT MONITOR