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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Hematocrit Measuring
510(k) Number K852482
Device Name MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94
Applicant
Em Diagnostic Systems, Inc.
480 Democrat Rd.
Gibbstown,  NJ  08027
Applicant Contact RAYMOND L MILLER
Correspondent
Em Diagnostic Systems, Inc.
480 Democrat Rd.
Gibbstown,  NJ  08027
Correspondent Contact RAYMOND L MILLER
Regulation Number864.6400
Classification Product Code
JPI  
Date Received06/11/1985
Decision Date 07/15/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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