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510(k) clearances

VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)

bioMerieux, Inc. · Microbiology

K260283Substantially EquivalentTraditionalLON
Open FDA's page for this record
Third party flag
N
City
Hazelwood
Advisory committee description
Microbiology
Address 1
595 Anglum Rd.
Statement or summary
Summary
Product code
LON
Zip code
63042
Applicant
bioMerieux, Inc.
Decision date
2026-10-01
Decision code
SESE
Country code
US
Device name
VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)
Advisory committee
MI
Contact
Esther Hernandez
K number
K260283
State
MO
Date received
2026-01-29
Review advisory committee
MI
Postal code
63042
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Medical specialty description
Microbiology
Regulation number
866.1645
Device class
2
Registration number
3031977134, 3025775667, 3009171251, 3007344102, 1111096, 1833407, 3007502289, 2022807, 3003030793, 3013718871, 1119779, 1318354, 3023036790, 3009637528, 3027320620, 3006198300, 1423662, 2919016, 3025772277, 3002444944, 3008007472, 3009288740, 1950204
FEI number
3031977134, 3025775667, 3007344102, 1111096, 3007502289, 1000518597, 3006759904, 2022807, 3003030793, 3013718871, 1119779, 1318354, 3023036790, 3009637528, 3027320620, 3006198300, 3000215273, 2919016, 3025772277, 3002444944, 3008007472, 3009288740, 1950204
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.