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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 K992759
Device Name COLON ALERT TEST
Applicant
Immunostics Inc.,
3505 Sunset Ave.
Ocean,  NJ  07712
Applicant Contact VINCENT P LASTELLA
Correspondent
Immunostics Inc.,
3505 Sunset Ave.
Ocean,  NJ  07712
Correspondent Contact VINCENT P LASTELLA
Regulation Number864.6550
Classification Product Code
KHE  
Date Received08/17/1999
Decision Date 12/06/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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