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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 K926090
Device Name SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT
Applicant
Syva Co.
P.O. Box 49013
San Jose,  CA  95161 -9013
Applicant Contact PAUL L ROGERS
Correspondent
Syva Co.
P.O. Box 49013
San Jose,  CA  95161 -9013
Correspondent Contact PAUL L ROGERS
Regulation Number866.3120
Classification Product Code
LJC  
Date Received12/02/1992
Decision Date 09/30/1993
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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