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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K844105
Device Name FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY
Applicant
Bartels Immunodiagnostic Supplies, Inc.
P.O. Box 3093
Bellevue,  WA  98009
Applicant Contact HOWARD TAYLOR
Correspondent
Bartels Immunodiagnostic Supplies, Inc.
P.O. Box 3093
Bellevue,  WA  98009
Correspondent Contact HOWARD TAYLOR
Date Received10/23/1984
Decision Date 12/06/1984
Decision Substantially Equivalent (SESE)
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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