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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-Sq. S.
Washington,  DC  20006
Applicant Contact LOTHAR GRIESSBACH
Correspondent
German American Chamber of Commerce, Inc.
One Farragut-Sq. S.
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
Predetermined Change
Control Plan Authorized
No
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