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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K950802
Device Name LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM
Applicant
International Enzymes, Inc.
1432-B S. Mission Rd.
Fallbrook,  CA  92028
Applicant Contact TEVA C ROTHWELL
Correspondent
International Enzymes, Inc.
1432-B S. Mission Rd.
Fallbrook,  CA  92028
Correspondent Contact TEVA C ROTHWELL
Regulation Number862.1660
Classification Product Code
JJY  
Date Received02/21/1995
Decision Date 06/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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