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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lowry (Colorimetric), Total Protein
510(k) Number K792347
Device Name MICRO LOWRY PROTEINTEST
Applicant
Panmed, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Panmed, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1635
Classification Product Code
JGP  
Date Received11/19/1979
Decision Date 12/06/1979
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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