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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Specimen Collection
510(k) Number K924053
Device Name CYTOQUANT COMBINED TRANSPORT MEDIA
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 Number866.2900
Classification Product Code
LIO  
Date Received08/12/1992
Decision Date 01/15/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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