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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name fluorescent immunoassay gentamicin
510(k) Number K852158
Device Name BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA
Applicant
BIOPROBE INTL., INC.
2842 walnut ave., suite c
tustin,  CA  92680
Applicant Contact perry g rucker
Correspondent
BIOPROBE INTL., INC.
2842 walnut ave., suite c
tustin,  CA  92680
Correspondent Contact perry g rucker
Regulation Number862.3450
Classification Product Code
LCQ  
Date Received05/17/1985
Decision Date 06/25/1985
Decision substantially equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
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