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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 K922327
Device Name DENLEY WELLPREP 2 SAMPLE PROCESSOR
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 Received05/11/1992
Decision Date 08/12/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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