OLYMPUS IGM REAGENT— 510(k) K073487

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K073487 for OLYMPUS IGM REAGENT, Substantially Equivalent on 2008-02-11. Applicant: Olympus America, Inc.. Device class: 2.

Clearance details

Applicant: Olympus America, Inc.
Product code: Code CFN
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2007-12-12
Decision date: 2008-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Co. Clare, IE

Download summary PDF View on FDA.gov ↗

Recent devices under product code CFN

K233663 — N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)2023-12-13
K221114 — Immunoglobulin G (IgG)2023-08-02
K192116 — Human IgA liquid reagent kit for Use on SPAPlus2019-09-04
K191985 — Optilite IgA Kit2019-08-19
K191635 — Optilite IgM Kit2019-07-15

More clearances from Olympus America, Inc.

K111788 — ENDOEYE HD II2012-01-13
K081615 — OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN2009-03-18
K073489 — OLYMPUS IGA REAGENT2008-02-11
K073490 — OLYMPUS IGG REAGENT2008-02-11
K062862 — OLYMPUS URIC ACID REAGENT, MODEL OSR6X982007-04-06

Recalls naming K073487

K-number listed on FDA's recall record

Z-2428-2024 — Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2Class II·Ongoing·Beckman Coulter Inc.·20240527

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K073487.

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