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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plates And Equipment, Radial Immunodiffusion
510(k) Number K881675
Device Name IMMULON 4 FLAT BOTTOM PLATES & REMOVAWELL STRIPS
Applicant
Dynatech Laboratories, Inc.
14340 Sullyfield Cir.
Chantilly,  VA  22021
Applicant Contact RICHARD K PRESCOTT
Correspondent
Dynatech Laboratories, Inc.
14340 Sullyfield Cir.
Chantilly,  VA  22021
Correspondent Contact RICHARD K PRESCOTT
Regulation Number866.4800
Classification Product Code
JZQ  
Date Received04/18/1988
Decision Date 04/21/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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