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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 K920302
Device Name PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY
Applicant
Gen-Probe, Inc.
9880 Campus Point Dr.
San Diego,  CA  92121
Applicant Contact RUBEN CHAIREZ
Correspondent
Gen-Probe, Inc.
9880 Campus Point Dr.
San Diego,  CA  92121
Correspondent Contact RUBEN CHAIREZ
Regulation Number866.3120
Classification Product Code
LSK  
Date Received01/21/1992
Decision Date 04/06/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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