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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, Multiple Biochemical Test
510(k) Number K874537
Device Name KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR
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 Number866.2320
Classification Product Code
JSE  
Date Received11/03/1987
Decision Date 11/20/1987
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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