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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 K883432
Device Name IMMUNOCCULT-LXI
Applicant
Intl. Immunoassay Laboratories, Inc.
1900 Wyatt Dr., #11
Santa Clara,  CA  95054
Applicant Contact SHAH, PHD
Correspondent
Intl. Immunoassay Laboratories, Inc.
1900 Wyatt Dr., #11
Santa Clara,  CA  95054
Correspondent Contact SHAH, PHD
Regulation Number864.6550
Classification Product Code
KHE  
Date Received08/15/1988
Decision Date 10/31/1988
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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