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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, General Use, Thin Layer Chromatography
510(k) Number K884176
Device Name CHROMATOGRAPHY KIT
Applicant
Gelman Sciences, Inc.
600 S Wagner Rd.
Ann Arbor,  MI  48103
Applicant Contact ANGELO PEREIRA
Correspondent
Gelman Sciences, Inc.
600 S Wagner Rd.
Ann Arbor,  MI  48103
Correspondent Contact ANGELO PEREIRA
Regulation Number862.2270
Classification Product Code
DPA  
Date Received10/04/1988
Decision Date 04/04/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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