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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dna-Reagents, Chlamydia
510(k) Number K990023
Device Name HYBRID CAPTURE II CT-ID TEST
Applicant
DIGENE CORP.
9000 VIRGINIA MANOR RD.,
BELTSVILLE,  MD  20705
Applicant Contact MARK DEL VECCHIO
Correspondent
DIGENE CORP.
9000 VIRGINIA MANOR RD.,
BELTSVILLE,  MD  20705
Correspondent Contact MARK DEL VECCHIO
Regulation Number866.3120
Classification Product Code
LSK  
Date Received01/05/1999
Decision Date 10/25/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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