CMV RQ BIO-ENZABEAD KIT— 510(k) K831343

Substantially Equivalent

Litton Bionetics

FDA 510(k) clearance K831343 for CMV RQ BIO-ENZABEAD KIT, Substantially Equivalent on 1983-08-08. Applicant: Litton Bionetics. Device class: 2.

Clearance details

Applicant: Litton Bionetics
Product code: Code LFZ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1983-04-25
Decision date: 1983-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFZ

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 Litton Bionetics

K840417 — EBNA ACIF KIT1984-12-27
K834443 — ROTAVIRUS BIO-ENZABEAD SCREEN KIT1984-03-16
K822985 — EBV-M KIT1982-12-03
K821804 — RUBELLA RQ BIO-ENZABEAD KIT1982-09-14
K801720 — TOXO BIO-BEAD TITRATION KIT1980-09-16

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