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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Microtiter Diluting/Dispensing
510(k) Number K894645
Device Name IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM
Applicant
Dynatech Laboratories, Inc.
14340 Sullyfield Cir.
Chantilly,  VA  22021
Applicant Contact BARRY LAZAR
Correspondent
Dynatech Laboratories, Inc.
14340 Sullyfield Cir.
Chantilly,  VA  22021
Correspondent Contact BARRY LAZAR
Regulation Number866.2500
Classification Product Code
JTC  
Date Received07/24/1989
Decision Date 10/17/1989
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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