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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 K880499
Device Name HEMOCCULT SENSITIVE TEST
Applicant
Smithkline Diagnostics, Inc.
225 Baypointe Pkwy.
San Jose,  CA  95134 -1622
Applicant Contact RONALD SCHOENGOLD
Correspondent
Smithkline Diagnostics, Inc.
225 Baypointe Pkwy.
San Jose,  CA  95134 -1622
Correspondent Contact RONALD SCHOENGOLD
Regulation Number864.6550
Classification Product Code
KHE  
Date Received02/05/1988
Decision Date 05/23/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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