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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, neisseria
510(k) Number K981485
Device Name HYBRID CAPTURE II GC-ID
Applicant
DIGENE CORP.
9000 virginia manor rd.,
beltsville,  MD  20705
Applicant Contact mark a del vecchio
Correspondent
DIGENE CORP.
9000 virginia manor rd.,
beltsville,  MD  20705
Correspondent Contact mark a del vecchio
Regulation Number866.3390
Classification Product Code
LSL  
Date Received04/24/1998
Decision Date 11/29/1999
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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