BARTELS CYTOMEGALOVIRUS IGG EIA— 510(k) K922582

Clearance details

Applicant

Baxter Diagnostics, Inc.

Product code

Code LFZ

Device class

Class 2

Regulation

21 CFR 866.3175

Advisory panel

Microbiology

Date received

1992-05-27

Decision date

1993-04-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bellevue, WA, US

• K220949 — Architect CMV IgG2022-10-27
• K220911 — Elecsys CMV IgG2022-10-12
• K181213 — ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control2018-07-30
• K163569 — Elecsys CMV IgM2017-03-17
• K162969 — LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set2017-01-06

• K934458 — DRIED GRAM-POSITIVE MIC/COMBO PANELS1995-07-18
• K950817 — DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI1995-04-25
• K935704 — DRIED GRAM-NEGATIVE MIC//COMBO PANELS1995-04-14
• K950570 — STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY1995-04-11
• K945235 — DRIED GRAM-POSITIVE MIC/COMBO PANELS1995-03-07