Atlas FDA

VITEK 2 GRAM POSITIVE MOXIFLOXACIN

FDA 510(k) clearance K032399 · decided 2003-09-10

Clearance details

K-number
K032399
Device name
VITEK 2 GRAM POSITIVE MOXIFLOXACIN
Applicant
bioMerieux, Inc.
Decision
Substantially Equivalent
Date received
2003-08-04
Decision date
2003-09-10
Days to decision
37 days
Clearance type
Traditional
Product code
LON
Device class
2
Regulation number
866.1645
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Hazelwood, MO, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226 recall (Z-0792-2023)Biomerieux Inc2023-01-04
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PMA approvals by this applicant

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THxID BRAF assay kit (P120014/S008)bioMerieux, Inc.2018-06-27
THxID-BRAF kit (P120014/S007)bioMerieux, Inc.2016-11-22
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