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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 K854423
Device Name IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES
Applicant
Dynatech Laboratories, Inc.
900 Slaters Ln.
Alexandria,  VA  22314
Applicant Contact BARRY S LAZAR
Correspondent
Dynatech Laboratories, Inc.
900 Slaters Ln.
Alexandria,  VA  22314
Correspondent Contact BARRY S LAZAR
Regulation Number866.2660
Classification Product Code
LIB  
Date Received11/05/1985
Decision Date 11/20/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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