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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 K915284
Device Name STACKING MICROPLATE WASHER
Applicant
Denley Instruments, Inc.
3 Bethesda Metro Center
Suite 750
Bethesda,  MD  20814
Applicant Contact JOYCE T.DAVIS
Correspondent
Denley Instruments, Inc.
3 Bethesda Metro Center
Suite 750
Bethesda,  MD  20814
Correspondent Contact JOYCE T.DAVIS
Regulation Number862.2750
Classification Product Code
JQW  
Date Received11/25/1991
Decision Date 01/22/1992
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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