HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY— 510(k) K962731

Name: FDA 510(k) clearance K962731
Creator: U.S. Food and Drug Administration
Published: 1997-03-07

Substantially Equivalent

Hycor Biomedical, Inc.

FDA 510(k) clearance K962731 for HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY, Substantially Equivalent on 1997-03-07. Applicant: Hycor Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Hycor Biomedical, Inc.
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1996-07-01
Decision date: 1997-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Garden Grove, 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 Hycor Biomedical, Inc.

view all

K081217 — HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM2008-05-22
K080322 — HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 2002008-03-05
K022944 — AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA2002-12-18
K022945 — AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA2002-12-18
K965094 — HYCOR ALLERGEN DISC1997-05-21

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