ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)— 510(k) K191953

Substantially Equivalent

Biomerieux S.A.

FDA 510(k) clearance K191953 for ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL), Substantially Equivalent on 2019-08-22. Applicant: Biomerieux S.A..

Clearance details

Applicant
Biomerieux S.A.
Product code
Code JWY
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Marcy-L'Etoile, FR
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