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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 K981567
Device Name HYBRID CAPTURE II CT/GC TEST
Applicant
DIGENE CORP.
9000 virginia manor rd.,
beltsville,  MD  20705
Contact mark a del vecchio
Regulation Number866.3390
Classification Product Code
LSL  
Subsequent Product Code
LSK  
Date Received05/01/1998
Decision Date 02/29/2000
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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