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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Erythrocyte Sedimentation Rate
510(k) Number K831195
Device Name WESTERGREN DISPETTE FOR ESR
Applicant
Ulster Scientific, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Ulster Scientific, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.6700
Classification Product Code
JPH  
Date Received04/12/1983
Decision Date 05/09/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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