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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K864863
Device Name DYNALUME(TM) REMOVAWELL STRIPS (NO. 011-010-7403)
Applicant
Dynatech Laboratories, Inc.
14340 Sullyfield Cir.
Chantilly,  VA  22021
Applicant Contact BARRY S LAZAR
Correspondent
Dynatech Laboratories, Inc.
14340 Sullyfield Cir.
Chantilly,  VA  22021
Correspondent Contact BARRY S LAZAR
Regulation Number862.1675
Classification Product Code
JKA  
Date Received12/11/1986
Decision Date 01/13/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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