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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 K781722
Device Name REAGENT SET, TOTAL PROTEIN
Applicant
Medical Analysis Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Medical Analysis Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1635
Classification Product Code
CEK  
Date Received10/11/1978
Decision Date 11/03/1978
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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