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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrolyte Controls (Assayed And Unassayed)
510(k) Number K955630
Device Name RNA MEDICAL HEMAT CONTROL
Applicant
Bionostics, Inc.
2 Craig Rd.
Acton,  MA  01720
Applicant Contact BRUCE R WILLIAMS
Correspondent
Bionostics, Inc.
2 Craig Rd.
Acton,  MA  01720
Correspondent Contact BRUCE R WILLIAMS
Regulation Number862.1660
Classification Product Code
JJR  
Subsequent Product Code
GLK  
Date Received12/11/1995
Decision Date 03/01/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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