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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 K860773
Device Name TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560
Applicant
Clinical Sciences, Inc.
30 Troy Rd.
Whippany,  NJ  07981
Applicant Contact MARYLOU PANICO
Correspondent
Clinical Sciences, Inc.
30 Troy Rd.
Whippany,  NJ  07981
Correspondent Contact MARYLOU PANICO
Regulation Number866.3780
Classification Product Code
LGD  
Date Received03/03/1986
Decision Date 05/23/1986
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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