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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 K010891
Device Name MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01
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 Number866.3120
Classification Product Code
LSK  
Subsequent Product Code
LSL  
Date Received03/26/2001
Decision Date 09/25/2001
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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