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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K940486
Device Name DIGENE DCR-1 LUMINOMETER
Applicant
Digene Diagnostics, Inc.
2301-B Broadbirch Dr.
Silver Spring,  MD  20904
Applicant Contact CHARLES M FLEISCHMAN
Correspondent
Digene Diagnostics, Inc.
2301-B Broadbirch Dr.
Silver Spring,  MD  20904
Correspondent Contact CHARLES M FLEISCHMAN
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received02/02/1994
Decision Date 04/18/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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