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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixture, Hematology Quality Control
510(k) Number K914099
Device Name GAS TRAK CONNECT BLOOD GAS CONTROL
Applicant
Biochemical Sciences, Inc.
603 Heron Dr.
P.O. Box 518
Bridgeport,  NJ  00801
Applicant Contact PHIL MUGLIE
Correspondent
Biochemical Sciences, Inc.
603 Heron Dr.
P.O. Box 518
Bridgeport,  NJ  00801
Correspondent Contact PHIL MUGLIE
Regulation Number864.8625
Classification Product Code
JPK  
Date Received09/12/1991
Decision Date 12/18/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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