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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 K852554
Device Name SRT-SYSTEM
Applicant
Microwave Development, Inc.
13 Arcadia Rd.
Old Greenwich,  CT  06870
Applicant Contact TOMAS WEHTJE
Correspondent
Microwave Development, Inc.
13 Arcadia Rd.
Old Greenwich,  CT  06870
Correspondent Contact TOMAS WEHTJE
Regulation Number864.6700
Classification Product Code
JPH  
Date Received06/17/1985
Decision Date 07/18/1985
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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