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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 K890154
Device Name MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA
Applicant
Labsystems, Inc.
Pulttitie 8
00880 Helsinki
Finland,  FI
Applicant Contact PAIVI SORMUNEN
Correspondent
Labsystems, Inc.
Pulttitie 8
00880 Helsinki
Finland,  FI
Correspondent Contact PAIVI SORMUNEN
Regulation Number866.3780
Classification Product Code
LGD  
Date Received01/12/1989
Decision Date 02/07/1989
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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