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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 K800287
Device Name CEPH LACTAM DISK
Applicant
Remel Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Remel Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.2320
Classification Product Code
JSF  
Date Received02/11/1980
Decision Date 03/19/1980
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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