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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K002804
Device Name N PROTEIN STANDARD SL
Applicant
Dade Behring, Inc.
Glasgow Business Community;
Bldg. 500 Mail Box 514
P.O. Box 6101, Newark,  DE  19714 -6101
Applicant Contact REBECCA S AYASH
Correspondent
Dade Behring, Inc.
Glasgow Business Community;
Bldg. 500 Mail Box 514
P.O. Box 6101, Newark,  DE  19714 -6101
Correspondent Contact REBECCA S AYASH
Regulation Number862.1150
Classification Product Code
JIX  
Date Received09/08/2000
Decision Date 10/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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