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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media And Components, Synthetic Cell And Tissue Culture
510(k) Number K821914
Device Name COON'S F-12 POWDER MEDIUM
Applicant
Dutchland Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Dutchland Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.2220
Classification Product Code
KIT  
Date Received06/28/1982
Decision Date 07/27/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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