Cleared Traditional

HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY

K962578 · Hycor Biomedical, Inc. · Immunology
Mar 1997
Decision
249d
Days
Class 2
Risk

About This 510(k) Submission

K962578 is an FDA 510(k) clearance for the HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY, a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL), submitted by Hycor Biomedical, Inc. (Garden Grove, US). The FDA issued a Cleared decision on March 7, 1997, 249 days after receiving the submission on July 1, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K962578 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1996
Decision Date March 07, 1997
Days to Decision 249 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code LLL — Extractable Antinuclear Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

Similar Devices — LLL Extractable Antinuclear Antibody, Antigen And Control

All 179
Alegria Flash CTD Screen
K250666 · Zeus Scientific · Oct 2025
Alegria Flash ENA Screen
K250408 · Zeus Scientific · Sep 2025
Aptiva CTD Essential Reagent
K213403 · Inova Diagnostics, Inc. · Sep 2023
EliA SymphonyS Immunoassay
K190710 · Phadia AB · Nov 2019
QUANTA Flash HMGCR Reagents
K180975 · Inova Diagnostics, Inc. · Jun 2018
QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls
K152635 · Inova Diagnostics, Inc. · Jun 2016