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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 K020894
Device Name CALIBRATING MATERIAL, CAL-PAK, BUFFERS
Applicant
Mission Diagnostics
331 Fiske St.
Holliston,  MA  01746
Applicant Contact LINDA STUNDTNER
Correspondent
Mission Diagnostics
331 Fiske St.
Holliston,  MA  01746
Correspondent Contact LINDA STUNDTNER
Regulation Number862.1150
Classification Product Code
JIT  
Date Received03/19/2002
Decision Date 04/29/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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