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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 K981795
Device Name CLEANING SOLUTION (1) MODEL NUMBER A943-795, SALT BRIDGE SOLUTION MODEL NUMBER A943-794, CALIBRATION SOLUTION, PH 7.4 MO
Applicant
Thermo Bioanalysis Corp.
333 Fiske St.
Holliston,  MA  01746
Applicant Contact JANET A MCGRATH
Correspondent
Thermo Bioanalysis Corp.
333 Fiske St.
Holliston,  MA  01746
Correspondent Contact JANET A MCGRATH
Regulation Number862.1150
Classification Product Code
JIX  
Subsequent Product Code
CHL  
Date Received05/21/1998
Decision Date 06/12/1998
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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