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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 K980120
Device Name DIGENE DML 2000 MICROPLATE LUMINOMETER
Applicant
DIGENE CORP.
9000 VIRGINIA MANOR RD.,
BELTSVILLE,  MD  20705
Applicant Contact CONSTANCE A FINCH
Correspondent
DIGENE CORP.
9000 VIRGINIA MANOR RD.,
BELTSVILLE,  MD  20705
Correspondent Contact CONSTANCE A FINCH
Regulation Number862.2300
Classification Product Code
JJQ  
Subsequent Product Code
KHO  
Date Received01/13/1998
Decision Date 02/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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