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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
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448