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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biuret (Colorimetric), Total Protein
510(k) Number K950128
Device Name TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2
Applicant
Emd Chemicals, Inc.
Div. Of Em Industries Inc.
480 Democrat Rd.
Gibbstown,  NJ  08027
Applicant Contact CAROL FAULKNER
Correspondent
Emd Chemicals, Inc.
Div. Of Em Industries Inc.
480 Democrat Rd.
Gibbstown,  NJ  08027
Correspondent Contact CAROL FAULKNER
Regulation Number862.1635
Classification Product Code
CEK  
Date Received01/12/1995
Decision Date 05/15/1995
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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