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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staphylococcus Aureus Somatic Antigens
510(k) Number K820531
Device Name ENDO-STAPH TEICHOIC ACID ANTIBODY KIT
Applicant
Meridian Diagnostics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Meridian Diagnostics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.3700
Classification Product Code
LHT  
Date Received03/02/1982
Decision Date 04/14/1982
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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