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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 K822334
Device Name BILIRUBIN CALIBRATORS
Applicant
GILFORD DIAGNOSTICS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
GILFORD DIAGNOSTICS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1150
Classification Product Code
JIT  
Date Received08/04/1982
Decision Date 09/02/1982
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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