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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
Predetermined Change
Control Plan Authorized		 No
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