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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 K940979
Device Name GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR
Applicant
GEN-PROBE, INC.
9880 campus point dr.
san diego,  CA  92121
Applicant Contact david e dunn
Correspondent
GEN-PROBE, INC.
9880 campus point dr.
san diego,  CA  92121
Correspondent Contact david e dunn
Regulation Number866.3390
Classification Product Code
LSL  
Date Received03/01/1994
Decision Date 10/31/1994
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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