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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
510(k) Number K833829
Device Name TOXOPLASMA GOND II IGG DIA TEST KIT
Applicant
Labsystems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Labsystems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.3780
Classification Product Code
LGD  
Date Received11/03/1983
Decision Date 04/24/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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