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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Dna Indirect Immunofluorescent Solid Phase
510(k) Number K861978
Device Name AUTOFLUOR V
Applicant
Technia Diagnostics , Ltd.
15th & Oak
P.O. Box 338
Elwood,  KS  66024
Applicant Contact JAMES A BAYLISS
Correspondent
Technia Diagnostics , Ltd.
15th & Oak
P.O. Box 338
Elwood,  KS  66024
Correspondent Contact JAMES A BAYLISS
Regulation Number866.5100
Classification Product Code
KTL  
Date Received05/21/1986
Decision Date 06/10/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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