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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, General Purpose, Microbiology, Diagnostic
510(k) Number K844476
Device Name PORTABLE DIAGNOSTIC LABORATORY
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 Number866.2660
Classification Product Code
LIB  
Date Received11/19/1984
Decision Date 03/13/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
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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