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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 K871076
Device Name WINPETTE
Applicant
Ulster Scientific, Inc.
P.O. Box 902
Highland,  NY  12528
Applicant Contact ROBERT K MCEWEN
Correspondent
Ulster Scientific, Inc.
P.O. Box 902
Highland,  NY  12528
Correspondent Contact ROBERT K MCEWEN
Regulation Number864.6700
Classification Product Code
JPH  
Date Received03/18/1987
Decision Date 03/23/1987
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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