CHROMID CARBA agar (CARB)— 510(k) K181092

Clearance details

Applicant

Biomerieux S.A.

Product code

Code JSO

Device class

Class 2

Regulation

21 CFR 866.1700

Advisory panel

Microbiology

Date received

2018-04-25

Decision date

2018-07-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Marcy-L'Etoile, FR

• K190553 — HardyCHROM CRE2019-04-29
• K171061 — MRSASelect II2017-12-28
• K162620 — Remel Spectra ESBL2017-05-01
• K160512 — HardyCHROM ESBL2016-11-15
• K162076 — chromID MRSA2016-10-25

• K250274 — ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)2025-04-30
• K210757 — ETEST Fosfomycin (FO) (0.032-512 µg/mL)2021-11-12
• K192738 — ETEST Delafloxacin (DFX) (0.002-32 µg/mL)2019-11-26
• K192050 — ETEST Eravacycline (ERV) (0.002 32 µg/mL)2019-09-27
• K191953 — ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)2019-08-22

Malfunction

602

Total

602

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0839-2023 — PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012Class II·Ongoing·Biomerieux Inc·20221109

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181092.