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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Calibrator, Primary
510(k) Number K760806
Device Name REFEREE AQUEOUS TRIGLYCERIDE STND
Applicant
ANALYTICAL PRODUCTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ANALYTICAL PRODUCTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1150
Classification Product Code
JIS  
Date Received10/12/1976
Decision Date 10/21/1976
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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