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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Propagating Transport
510(k) Number K961755
Device Name CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM
Applicant
Proteins Intl., Inc.
1858 Star Batt Dr.
Rochester Hills,  MI  48309
Applicant Contact NAOMI ELIEZER
Correspondent
Proteins Intl., Inc.
1858 Star Batt Dr.
Rochester Hills,  MI  48309
Correspondent Contact NAOMI ELIEZER
Regulation Number866.2390
Classification Product Code
JSN  
Date Received05/06/1996
Decision Date 05/17/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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