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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Supplement, Culture Media
510(k) Number K831469
Device Name LEGIONELLA CYE AGAR BASE & BCYE SUPPL
Applicant
OXOID U.S.A., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
OXOID U.S.A., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number866.2450
Classification Product Code
JSK  
Date Received05/06/1983
Decision Date 06/08/1983
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
Recalls CDRH Recalls
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