IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB— 510(k) K000121

Name: FDA 510(k) clearance K000121
Creator: U.S. Food and Drug Administration
Published: 2000-05-17

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K000121 for IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB, Substantially Equivalent on 2000-05-17. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code DFC
Device class: Class 2
Regulation: 21 CFR 866.5600
Advisory panel: Immunology
Date received: 2000-01-18
Decision date: 2000-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DFC

view all

K253069 — Lipoprotein (a) Molarity Assay2026-06-16
K241220 — Tina-quant Lipoprotein(a) Gen.2 Molarity2025-01-24
K211058 — Lp(a) Ultra2022-12-22
K180074 — Diazyme Lipoprotein (a) Assay2018-03-22
K123046 — ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR2012-12-20

More clearances from Beckman Coulter, Inc.

view all

K252169 — Access BNP II2026-03-24
K254059 — Access anti-HBc IgM2026-03-13
K253687 — Access anti-HBc Total2026-02-19
K251995 — Access anti-HAV IgM2026-01-27
K250588 — Access Rubella IgG2025-11-17

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