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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Station, Pipetting And Diluting, For Clinical Use
510(k) Number K861640
Device Name MODUMATIC (R) DILUTER
Applicant
Tri-Continent Scientific, Inc.
12555 Loma Rica Dr., #2
Grass Valley,  CA  95945
Applicant Contact GARY W MCCLUSKEY
Correspondent
Tri-Continent Scientific, Inc.
12555 Loma Rica Dr., #2
Grass Valley,  CA  95945
Correspondent Contact GARY W MCCLUSKEY
Regulation Number862.2750
Classification Product Code
JQW  
Date Received04/30/1986
Decision Date 05/23/1986
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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