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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K822937
Device Name GLUCOSE/UREA NITROGEN STANDARD
Applicant
Emd Chemicals, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Emd Chemicals, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1150
Classification Product Code
JIX  
Date Received10/04/1982
Decision Date 11/05/1982
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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