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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controls For Blood-Gases, (Assayed And Unassayed)
510(k) Number K922357
Device Name RNA MEDICAL'S EQUIL 55
Applicant
BIONOSTICS, INC.
TWO CRAIG RD.
ACTON,  MA  01720
Applicant Contact BRUCE R WILLIAMS
Correspondent
BIONOSTICS, INC.
TWO CRAIG RD.
ACTON,  MA  01720
Correspondent Contact BRUCE R WILLIAMS
Regulation Number862.1660
Classification Product Code
JJS  
Date Received05/19/1992
Decision Date 06/30/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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