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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, C-Reactive Protein
510(k) Number K904497
Device Name CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST
Applicant
BIOTRAX, INC.
5202 WESTLAND BLVD.
BALTIMORE,  MD  21227
Applicant Contact SANTO GRILLO
Correspondent
BIOTRAX, INC.
5202 WESTLAND BLVD.
BALTIMORE,  MD  21227
Correspondent Contact SANTO GRILLO
Regulation Number866.5270
Classification Product Code
DCN  
Date Received10/02/1990
Decision Date 11/01/1990
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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