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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Iodine, Grams
510(k) Number K871286
Device Name GRAM IODINE
Applicant
Remel Co.
12076 Santa Fe Dr.
Lenexa,  KS  66215
Applicant Contact JAMES G BAXENDALE
Correspondent
Remel Co.
12076 Santa Fe Dr.
Lenexa,  KS  66215
Correspondent Contact JAMES G BAXENDALE
Regulation Number864.1850
Classification Product Code
HYI  
Date Received03/31/1987
Decision Date 04/08/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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