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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, Non-Selective And Non-Differential
510(k) Number K881533
Device Name BLOOD AGAR BASE NO. 2
Applicant
ACUMEDIA MANUFACTURERS, INC.
3651 CLIPPER MILL RD.
BALTIMORE,  MD  21211
Applicant Contact CUNNINGHAM, PHD
Correspondent
ACUMEDIA MANUFACTURERS, INC.
3651 CLIPPER MILL RD.
BALTIMORE,  MD  21211
Correspondent Contact CUNNINGHAM, PHD
Regulation Number866.2300
Classification Product Code
JSG  
Date Received04/08/1988
Decision Date 04/18/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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