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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, (Chlamydiae Group)
510(k) Number K920503
Device Name SYVA MICROTRAK CHLAMYDIA EIA
Applicant
Syva Co.
P.O. Box 49013
San Jose,  CA  95161 -9013
Applicant Contact ROGERS, JR.
Correspondent
Syva Co.
P.O. Box 49013
San Jose,  CA  95161 -9013
Correspondent Contact ROGERS, JR.
Regulation Number866.3120
Classification Product Code
LJC  
Date Received02/05/1992
Decision Date 09/25/1992
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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