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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K930199
Device Name ALKO FLUIDS PACKS FOR NOVA ANALYZERS
Applicant
Alko Diagnostic Corp.
Alko Park
333 Fiske St.
Holliston,  MA  01746
Applicant Contact BRIAN J YOUNG
Correspondent
Alko Diagnostic Corp.
Alko Park
333 Fiske St.
Holliston,  MA  01746
Correspondent Contact BRIAN J YOUNG
Regulation Number862.1150
Classification Product Code
JIX  
Date Received01/14/1993
Decision Date 01/13/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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