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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, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
510(k) Number K882351
Device Name MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181
Applicant
Lakewood Biochemical Co., Inc.
2111 Irving Blvd.
Dallas,  TX  75207
Applicant Contact JOHN E PEDIGO
Correspondent
Lakewood Biochemical Co., Inc.
2111 Irving Blvd.
Dallas,  TX  75207
Correspondent Contact JOHN E PEDIGO
Regulation Number866.1700
Classification Product Code
JTZ  
Date Received06/07/1988
Decision Date 06/28/1988
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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