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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 K855036
Device Name CHEMISTRY CONTROL N & A
Applicant
Integrated Medical Systems Int'L., Inc.
316 Ash St.
Mc Allen,  TX  78501
Applicant Contact JAMES LENAR
Correspondent
Integrated Medical Systems Int'L., Inc.
316 Ash St.
Mc Allen,  TX  78501
Correspondent Contact JAMES LENAR
Regulation Number862.1660
Classification Product Code
JJY  
Date Received12/17/1985
Decision Date 03/17/1986
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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