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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 K873293
Device Name BIOTROL TOXO ELISA TEST M
Applicant
Biotrol, USA, Inc.
5 Great Valley Pkwy., Suite 248
Great Valley Corp. Center
Malvern,  PA  19355
Applicant Contact ALLAN C MURPHY
Correspondent
Biotrol, USA, Inc.
5 Great Valley Pkwy., Suite 248
Great Valley Corp. Center
Malvern,  PA  19355
Correspondent Contact ALLAN C MURPHY
Regulation Number866.3780
Classification Product Code
LGD  
Date Received08/17/1987
Decision Date 04/12/1988
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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