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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Gentamicin
510(k) Number K010984
Device Name EMIT 2000 GENTAMICIN PLUS ASSAY
Applicant
Syva Co., Dade Behring, Inc.
3403 Yerba Buena Rd.
San Jose,  CA  95135
Applicant Contact VIRGINIA SINGER
Correspondent
Syva Co., Dade Behring, Inc.
3403 Yerba Buena Rd.
San Jose,  CA  95135
Correspondent Contact VIRGINIA SINGER
Regulation Number862.3450
Classification Product Code
LCD  
Date Received04/02/2001
Decision Date 04/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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