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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Products, Red-Cell Lysing Products
510(k) Number K802742
Device Name SERA-PAK TOTAL PROTEIN REAGENT
Applicant
Miles Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Miles Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number864.8540
Classification Product Code
GGK  
Date Received11/03/1980
Decision Date 12/11/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
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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