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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Station, Pipetting And Diluting, For Clinical Use
510(k) Number K873416
Device Name MULTI-ACCESS REAGENT DISPENSER
Applicant
Electro-Nucleonics Laboratories, Inc.
7101 Riverwood Dr.
Columbia,  MD  21046
Applicant Contact LABREC, PH.D.
Correspondent
Electro-Nucleonics Laboratories, Inc.
7101 Riverwood Dr.
Columbia,  MD  21046
Correspondent Contact LABREC, PH.D.
Regulation Number862.2750
Classification Product Code
JQW  
Date Received08/25/1987
Decision Date 10/09/1987
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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