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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name media and components, mycoplasma detection
510(k) Number K781874
Device Name MYCOPLASMA ARGININI FITC (30-403-41)
Original Applicant
Regulation Number864.2360
Classification Product Code
Date Received11/03/1978
Decision Date 12/20/1978
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No