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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K972868
Device Name TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE 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
JJY  
Date Received08/04/1997
Decision Date 08/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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