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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 K010893
Device Name MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01
Applicant
DIGENE CORP.
1201 CLOPPER RD.
GAITHERSBURG,  MD  20878
Applicant Contact MARK A DEL VECCHIO
Correspondent
DIGENE CORP.
1201 CLOPPER RD.
GAITHERSBURG,  MD  20878
Correspondent Contact MARK A DEL VECCHIO
Regulation Number866.3390
Classification Product Code
LSL  
Date Received03/26/2001
Decision Date 09/24/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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