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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 K770765
Device Name REAGENT SET, RENORPACE
Applicant
G.D. Searle and Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
G.D. Searle and Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2270
Classification Product Code
DPA  
Date Received04/27/1977
Decision Date 06/24/1977
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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