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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cells, Animal And Human, Cultured
510(k) Number K930325
Device Name CYTOQUANT(TM) MDCK CANINE KIDNEY CELLS
Applicant
Proteins Intl., Inc.
1858 Star Batt Dr.
Rochester Hills,  MI  48309
Applicant Contact VICTORIA E WALLEY
Correspondent
Proteins Intl., Inc.
1858 Star Batt Dr.
Rochester Hills,  MI  48309
Correspondent Contact VICTORIA E WALLEY
Regulation Number864.2280
Classification Product Code
KIR  
Date Received01/22/1993
Decision Date 03/23/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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