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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nitroprusside, Ketones (Urinary, Non-Quant.)
510(k) Number K910108
Device Name GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED
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 Number862.1435
Classification Product Code
JIN  
Date Received01/10/1991
Decision Date 03/04/1991
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
Recalls CDRH Recalls
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