VIDAS CMV IGM ASSAY— 510(k) K933549

Substantially Equivalent

Biomerieux Vitek, Inc.

FDA 510(k) clearance K933549 for VIDAS CMV IGM ASSAY, Substantially Equivalent on 1994-08-02. Applicant: Biomerieux Vitek, Inc.. Device class: 2.

Clearance details

Applicant: Biomerieux Vitek, Inc.
Product code: Code LKQ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1993-07-22
Decision date: 1994-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LKQ

K100433 — IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,2010-05-13
K972884 — ACCURUN 146 CMV IGM POSITIVE CONTROL1997-08-22
K922580 — BARTELS CYTOMEGALOVIRUS IGM EIA1993-04-08
K914789 — ELISA CMV IGM1992-03-04
K913080 — OPUS(R) ANTI CMV-M1991-10-28

More clearances from Biomerieux Vitek, Inc.

K973819 — VIDAS D-DIMER (DD) ASSAY1998-03-10
K972895 — VIDAS ROTAVIRUS (RTV) ASSAY1997-10-03
K965092 — VIDAS ROTAVIRUS ASSAY1997-05-05
K964887 — VIDAS C. DIFFICILE TOXIN A II ASSAY1997-04-08
K955627 — VIDAS CHLAMYDIA BLOCKING ASSAY1996-10-07

Recalls naming K933549

K-number listed on FDA's recall record

Z-0742-2022 — VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.Class II·Terminated·bioMerieux, Inc.·20220209
Z-1408-2021 — VIDAS¿ CMV IgM 30 TestsClass II·Terminated·Biomerieux Inc·20210316

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K933549.

Data sourced from openFDA. This site is unofficial and independent of the FDA.