PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT— 510(k) K982023

Name: FDA 510(k) clearance K982023
Creator: U.S. Food and Drug Administration
Published: 1998-09-04

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K982023 for PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT, Substantially Equivalent on 1998-09-04. Applicant: Inova Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code DAS
Device class: Class 1
Regulation: 21 CFR 866.5530
Advisory panel: Immunology
Date received: 1998-06-09
Decision date: 1998-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DAS

view all

K944876 — HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT1994-12-15
K943098 — HUMAN IGG SUBCLASSES ELISA COMBI KIT1994-09-07
K943205 — HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION)1994-09-07
K895600 — HUMAN (IGG) SUBCLASS (EIA) KIT1989-11-08
K790708 — ANTISERUM TO HUMAN IG G FC FRAGMENTS1979-08-22

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.