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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Occult Blood
510(k) Number K843532
FOIA Releasable 510(k) K843532
Device Name UROPAPER EIKEN 8
Applicant
Syn-Kit, Inc.
9231 Eton Ave.
Chatsworth,  CA  91311
Applicant Contact IWAO MATSUOKA
Correspondent
Syn-Kit, Inc.
9231 Eton Ave.
Chatsworth,  CA  91311
Correspondent Contact IWAO MATSUOKA
Regulation Number864.6550
Classification Product Code
KHE  
Date Received09/07/1984
Decision Date 12/12/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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