QUANTA LITE SP100 ELISA— 510(k) K050662

Name: FDA 510(k) clearance K050662
Creator: U.S. Food and Drug Administration
Published: 2005-06-13

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K050662 for QUANTA LITE SP100 ELISA, Substantially Equivalent on 2005-06-13. Applicant: Inova Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code NUM
Device class: Class 2
Regulation: 21 CFR 866.5090
Advisory panel: Immunology
Date received: 2005-03-15
Decision date: 2005-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

More clearances from Inova Diagnostics, Inc.

view all

K243979 — Aptiva APS IgA Reagent2026-02-06
K223093 — Aptiva APS IgG Reagent; Aptiva APS IgM Reagent2024-12-17
K213403 — Aptiva CTD Essential Reagent2023-09-29
K200230 — Aptiva Celiac Disease IgG Reagent2021-08-26
K193604 — Aptiva Celiac Disease IgA Reagent2021-06-16

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