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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Surrogate
510(k) Number K854028
Device Name AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER
Applicant
Verified Medical Research, Inc.
124 E. Harvard
Tempe,  AZ  85283
Applicant Contact GARY W SHIRES
Correspondent
Verified Medical Research, Inc.
124 E. Harvard
Tempe,  AZ  85283
Correspondent Contact GARY W SHIRES
Regulation Number862.1150
Classification Product Code
JIW  
Date Received10/01/1985
Decision Date 12/02/1985
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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