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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chromatography For Bacterial Identification
510(k) Number K834007
Device Name CYSTINE TRYPTIC MEDIUM
Applicant
Micro Media Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Micro Media Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2250
Classification Product Code
JSQ  
Date Received11/21/1983
Decision Date 12/22/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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