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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 K855199
Device Name PARAMAX COMPREHENSIVE CALIBRATOR
Applicant
American Dade
P.O. Box 25101
Santa Ana,  CA  92799
Applicant Contact JAMES E KELLER
Correspondent
American Dade
P.O. Box 25101
Santa Ana,  CA  92799
Correspondent Contact JAMES E KELLER
Regulation Number862.1150
Classification Product Code
JIX  
Date Received12/27/1985
Decision Date 02/19/1986
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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