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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 K850202
Device Name GELMAN TRIPHOR CONTROL
Applicant
Gelman Sciences, Inc.
600 S Wagner Rd.
Ann Arbor,  MI  48103
Applicant Contact HARWOOD GREEN
Correspondent
Gelman Sciences, Inc.
600 S Wagner Rd.
Ann Arbor,  MI  48103
Correspondent Contact HARWOOD GREEN
Regulation Number862.1660
Classification Product Code
JJY  
Date Received01/18/1985
Decision Date 02/06/1985
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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