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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, Single Biochemical Test
510(k) Number K850194
Device Name CAFFEIC ACID DISK
Applicant
Remel Co.
12076 Santa Fe Dr.
Lenexa,  KS  66215
Applicant Contact JAMES G BAXENDALE
Correspondent
Remel Co.
12076 Santa Fe Dr.
Lenexa,  KS  66215
Correspondent Contact JAMES G BAXENDALE
Regulation Number866.2320
Classification Product Code
JSF  
Date Received01/18/1985
Decision Date 04/22/1985
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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