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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
510(k) Number K853041
Device Name TRIGLYCERIDES LCK 124
Applicant
GERMAN AMERICAN CHAMBER OF COMMERCE, INC.
ONE FARRAGUT-SQUARE SOUTH
WASHINGTON,  DC  20006
Applicant Contact LOTHAR GRIESSBACH
Correspondent
GERMAN AMERICAN CHAMBER OF COMMERCE, INC.
ONE FARRAGUT-SQUARE SOUTH
WASHINGTON,  DC  20006
Correspondent Contact LOTHAR GRIESSBACH
Regulation Number862.1795
Classification Product Code
CDF  
Date Received07/19/1985
Decision Date 08/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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