chromID MRSA— 510(k) K162076

Clearance details

Applicant

bioMerieux, Inc.

Product code

Code JSO

Device class

Class 2

Regulation

21 CFR 866.1700

Advisory panel

Microbiology

Date received

2016-07-27

Decision date

2016-10-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hazelwood, MO, US

• K190553 — HardyCHROM CRE2019-04-29
• K181092 — CHROMID CARBA agar (CARB)2018-07-06
• K171061 — MRSASelect II2017-12-28
• K162620 — Remel Spectra ESBL2017-05-01
• K160512 — HardyCHROM ESBL2016-11-15

• K260160 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST System2026-07-08
• K260282 — VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance2026-04-15
• K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)2025-08-21
• K234012 — VITEK COMPACT PRO2025-03-14
• K232967 — VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)2024-06-12

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-0802-2023 — PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841Class II·Ongoing·Biomerieux Inc·20221109
• Z-0842-2023 — PPM CLINICAL CHROMID MRSA S AUREUS 20PLT US, CATALOG 414524Class II·Ongoing·Biomerieux Inc·20221109

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162076.