Atlas FDA

VITEK 2 AST-YS FLUCONAZOLE

FDA 510(k) clearance K061945 · decided 2006-09-19

Clearance details

K-number
K061945
Device name
VITEK 2 AST-YS FLUCONAZOLE
Applicant
bioMerieux, Inc.
Decision
Substantially Equivalent
Date received
2006-07-10
Decision date
2006-09-19
Days to decision
71 days
Clearance type
Traditional
Product code
NGZ
Device class
2
Regulation number
866.1640
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Hazelwood, MO, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

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Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL (K221198)Thermo Fisher Scientific2023-03-10
The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml (K221899)Thermo Fisher Scientific2023-01-20
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VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL) (K181368)bioMerieux, Inc.2018-06-20
VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) (K151923)bioMerieux, Inc.2016-03-25
VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL (K151817)bioMerieux, Inc.2016-02-18
VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE (K133952)bioMerieux, Inc.2014-08-19
VITEK 2 AST - YEAST FLUCONAZOLE (K133817)bioMerieux, Inc.2014-08-05

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
THXID™-BRAF (P120014/S012)bioMerieux, Inc.2021-12-20
THxID-BRAF kit (P120014/S011)bioMerieux, Inc.2021-03-10
THxID-BRAF assay kit (P120014/S010)bioMerieux, Inc.2020-02-26
THxID BRAF assay kit (P120014/S009)bioMerieux, Inc.2019-08-26
THxID BRAF assay kit (P120014/S008)bioMerieux, Inc.2018-06-27
THxID-BRAF kit (P120014/S007)bioMerieux, Inc.2016-11-22
VIDAS TOTAL PSA (P040008/S013)bioMerieux, Inc.2016-05-31
THXID-BRAF KIT (P120014/S006)bioMerieux, Inc.2016-04-05