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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetry, Acetaminophen
510(k) Number K931257
Device Name ACETASITE
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 Number862.3030
Classification Product Code
LDP  
Date Received03/12/1993
Decision Date 07/08/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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