LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206— 510(k) K984462

Name: FDA 510(k) clearance K984462
Creator: U.S. Food and Drug Administration
Published: 1998-12-22

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K984462 for LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206, Substantially Equivalent on 1998-12-22. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1998-12-16
Decision date: 1998-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLL

view all

K253817 — IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La2026-08-21
K253367 — EliA CTD 13 Screen2026-06-25
K250666 — Alegria Flash CTD Screen2025-10-22
K250408 — Alegria Flash ENA Screen2025-09-19
K213403 — Aptiva CTD Essential Reagent2023-09-29

More clearances from Bio-Rad

view all

K171061 — MRSASelect II2017-12-28
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

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