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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, If, Toxoplasma Gondii
510(k) Number K772243
Device Name TOXO TEST
Applicant
Gull Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Gull Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3780
Classification Product Code
GLZ  
Date Received12/08/1977
Decision Date 12/22/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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