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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 K884177
Device Name DRUG STANDARD SET
Applicant
Gelman Sciences, Inc.
600 S. Wagner Rd.
Ann Arbor,  MI  48103 -9019
Applicant Contact ANGELO PEREIRA
Correspondent
Gelman Sciences, Inc.
600 S. Wagner Rd.
Ann Arbor,  MI  48103 -9019
Correspondent Contact ANGELO PEREIRA
Regulation Number862.3200
Classification Product Code
DKB  
Date Received10/04/1988
Decision Date 02/17/1989
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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