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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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GTI-MACE (Modified Capture ELISA)

Applicant: Genetic Testing Institute Brookfield, WI

510(k) number: BK000031

Product: GTI-MACE (Modified Capture ELISA)

Date: 1/29/2001



Supporting Documents


Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002