MRSASelect II— 510(k) K171061

Clearance details

Applicant

Bio-Rad

Product code

Code JSO

Device class

Class 2

Regulation

21 CFR 866.1700

Advisory panel

Microbiology

Date received

2017-04-10

Decision date

2017-12-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

92430 Marnes-La-Coquette, FR

• K190553 — HardyCHROM CRE2019-04-29
• K181092 — CHROMID CARBA agar (CARB)2018-07-06
• K162620 — Remel Spectra ESBL2017-05-01
• K160512 — HardyCHROM ESBL2016-11-15
• K162076 — chromID MRSA2016-10-25

• K122187 — VRESELECT CULTURE MEDIUM2012-11-06
• K103684 — VRESELECT CULTURE MEDIUM2011-10-21
• K093678 — PLATELIA ASPERGILLUS EIA MODEL 627932011-01-13
• K100589 — MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS2010-10-29
• K081362 — PLATELIA LYME IGM2008-06-26

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-1743-2019 — MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.Class II·Terminated·Bio-Rad Laboratories, Inc·20180608

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171061.