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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K000783
Device Name DIRECT TIBC CALIBRATOR
Applicant
REFERENCE DIAGNOSTICS, INC.
23 CROSBY DR.
BEDFORD,  MA  01730
Applicant Contact JOSEPH LAWLOR
Correspondent
REFERENCE DIAGNOSTICS, INC.
23 CROSBY DR.
BEDFORD,  MA  01730
Correspondent Contact JOSEPH LAWLOR
Regulation Number862.1150
Classification Product Code
JIT  
Date Received03/10/2000
Decision Date 05/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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