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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 K873611
Device Name A-QC CLINICAL CHEMISTRY CONTROL
Applicant
Arden Medical Systems, Inc.
2675 Long Lake Rd.
P.O. Box 64302
Roseville,  MN  55113
Applicant Contact BARBARA E ROTH
Correspondent
Arden Medical Systems, Inc.
2675 Long Lake Rd.
P.O. Box 64302
Roseville,  MN  55113
Correspondent Contact BARBARA E ROTH
Regulation Number862.1660
Classification Product Code
JJY  
Date Received09/08/1987
Decision Date 10/20/1987
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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