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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetry, Salicylate
510(k) Number K882038
Device Name GDS ENZYMATIC SALICYLATE REAGENT
Applicant
Gds Technology, LLC
25235 Leer Dr.
P.O. Box 473
Elkhart,  IN  46515
Applicant Contact DE CASTRO
Correspondent
Gds Technology, LLC
25235 Leer Dr.
P.O. Box 473
Elkhart,  IN  46515
Correspondent Contact DE CASTRO
Regulation Number862.3830
Classification Product Code
DKJ  
Date Received05/16/1988
Decision Date 06/24/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
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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