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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 K884266
Device Name PH BLOOD GAS CONTROL PRODUCTS
Applicant
Alko Diagnostic Corp.
Alko Park
333 Fiske St.
Holliston,  MA  01746
Applicant Contact J KOVACS
Correspondent
Alko Diagnostic Corp.
Alko Park
333 Fiske St.
Holliston,  MA  01746
Correspondent Contact J KOVACS
Regulation Number864.8625
Classification Product Code
JPK  
Date Received10/11/1988
Decision Date 05/16/1989
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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