PHARMACIA CMV IGM ELISA— 510(k) K921011

Name: FDA 510(k) clearance K921011
Creator: U.S. Food and Drug Administration
Published: 1992-07-27

Substantially Equivalent

Pharmacia Diagnostics, Inc.

FDA 510(k) clearance K921011 for PHARMACIA CMV IGM ELISA, Substantially Equivalent on 1992-07-27. Applicant: Pharmacia Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Pharmacia Diagnostics, Inc.
Product code: Code LFZ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1992-03-03
Decision date: 1992-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Piscataway, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFZ

view all

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

More clearances from Pharmacia Diagnostics, Inc.

view all

K920702 — TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO1992-07-08
K915348 — EBV-VCA IGM ELISA1992-02-14
K914022 — SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS1992-01-27
K912026 — DELFIA(R) 17 -OH-PROGESTERON KIT1991-06-25
K902793 — RUBELLA IGG1990-07-31

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