Atlas FDA

GEN-PROBE APTIMA COMBO 2 ASSAY

FDA 510(k) clearance K022874 · decided 2002-09-17

Clearance details

K-number
K022874
Device name
GEN-PROBE APTIMA COMBO 2 ASSAY
Applicant
Gen-Probe, Inc.
Decision
Substantially Equivalent
Date received
2002-07-26
Decision date
2002-09-17
Days to decision
53 days
Clearance type
Traditional
Product code
JTW
Device class
1
Regulation number
866.2900
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
San Diego, CA, US
Third-party review
No
Expedited review
No

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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