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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrators, Drug Mixture
510(k) Number K910881
Device Name CONTROL AND LINEARITY
Applicant
Gds Diagnostics
25235 Leer Dr.
P.O. Box 473
Elkhart,  IN  46515
Applicant Contact DE CASTRO
Correspondent
Gds Diagnostics
25235 Leer Dr.
P.O. Box 473
Elkhart,  IN  46515
Correspondent Contact DE CASTRO
Regulation Number862.3200
Classification Product Code
DKB  
Date Received03/01/1991
Decision Date 09/13/1991
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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