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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Beta-2-Microglobulin Immunological
510(k) Number K002731
Device Name N LATEX B2-MICROGLOBULIN
Applicant
Dade Behring, Inc.
7739 NW 48 St.
Suite 120
Miami,  FL  33166
Applicant Contact RADAMES RIESGO
Correspondent
Dade Behring, Inc.
7739 NW 48 St.
Suite 120
Miami,  FL  33166
Correspondent Contact RADAMES RIESGO
Regulation Number866.5630
Classification Product Code
JZG  
Date Received09/01/2000
Decision Date 11/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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