Atlas FDA

ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)

FDA 510(k) clearance K191953 · decided 2019-08-22

Clearance details

K-number
K191953
Device name
ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
Applicant
Biomerieux S.A.
Decision
Substantially Equivalent
Date received
2019-07-22
Decision date
2019-08-22
Days to decision
31 days
Clearance type
Traditional
Product code
JWY
Device class
2
Regulation number
866.1640
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Marcy-L'Etoile, FR
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927 recall (Z-0849-2023)Biomerieux Inc2023-01-04