Atlas FDA

GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088

FDA 510(k) clearance K053446 · decided 2006-07-25

Clearance details

K-number
K053446
Device name
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088
Applicant
Gen-Probe, Inc.
Decision
Substantially Equivalent
Date received
2005-12-12
Decision date
2006-07-25
Days to decision
225 days
Clearance type
Traditional
Product code
MKZ
Device class
1
Regulation number
866.3120
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
San Diego, CA, US
Third-party review
No
Expedited review
No

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Aptima® Chlamydia trachomatis Assay (K230451)Hologic, Inc.2023-11-16
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COBAS 4800 CT / NG TEST (K110923)Roche Molecular Systems, Inc.2012-01-24
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY (K091724)Becton, Dickinson & CO2009-11-13
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BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY (K081824)Becton, Dickinson & CO2008-12-11
ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT (K080739)Abbott Molecular, Inc.2008-07-10
AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY (K070174)Roche Diagnostics Corporation2007-04-16
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 (K063451)Gen-Probe, Inc.2007-01-22
APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM (K061413)Gen-Probe, Inc.2006-10-13
COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS (K053287)Roche Diagnostics Corp.2006-08-10
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS (K043072)Gen-Probe, Inc.2005-01-27

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST (P940034/S019)Gen-Probe, Inc.2012-12-05
AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST (P940034/S018)Gen-Probe, Inc.2010-04-23
GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD) (P940034/S017)Gen-Probe, Inc.2007-07-18
GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (P940034/S016)Gen-Probe, Inc.2004-10-08
GEN-PROBE ABPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (P940034/S015)Gen-Probe, Inc.2004-02-10
GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST(MTD TEST) (P940034/S013)Gen-Probe, Inc.2002-01-25
GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (P940034/S012)Gen-Probe, Inc.2001-08-30
GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST) (P940034/S011)Gen-Probe, Inc.2000-11-21