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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K944516
Device Name FLUIDS PACK
Applicant
Alko Diagnostic Corp.
333 Fiske St.
Holliston,  MA  01746
Applicant Contact BRIAN J YOUNG
Correspondent
Alko Diagnostic Corp.
333 Fiske St.
Holliston,  MA  01746
Correspondent Contact BRIAN J YOUNG
Regulation Number862.1150
Classification Product Code
JIT  
Date Received09/15/1994
Decision Date 11/02/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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