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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 K930386
Device Name 16 X 125 MM TEST TUBE, CATALOG #01-401
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 Received01/26/1993
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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