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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemocytometer
510(k) Number K871671
Device Name URINOSCOPY FUNNEL
Applicant
Portable Medical Laboratories, Inc.
P.O. Box 667
Solana Beach,  CA  92075
Applicant Contact WARREN R SANBORN
Correspondent
Portable Medical Laboratories, Inc.
P.O. Box 667
Solana Beach,  CA  92075
Correspondent Contact WARREN R SANBORN
Regulation Number864.6160
Classification Product Code
GHO  
Date Received04/28/1987
Decision Date 05/20/1987
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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