ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953— 510(k) K061190

Name: FDA 510(k) clearance K061190
Creator: U.S. Food and Drug Administration
Published: 2006-09-15

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K061190 for ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953, Substantially Equivalent on 2006-09-15. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code CEW
Device class: Class 2
Regulation: 21 CFR 862.1545
Advisory panel: Clinical Chemistry
Date received: 2006-04-28
Decision date: 2006-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CEW

view all

K231927 — Elecsys PTH , Elecsys PTH STAT2024-03-22
K232791 — Access Intact PTH2024-03-01
K221197 — VITROS Immunodiagnostic Products Intact PTH II Reagent Pack2023-09-05
K190702 — Lumipulse G whole PTH2019-08-30
K163658 — ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay2017-05-23

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

Adverse events under product code CEW

product code CEW

Malfunction: 480
Total: 480

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K061190

K-number listed on FDA's recall record

Z-0803-2025 — Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems, Catalog Number A16972Class II·Ongoing·Beckman Coulter, Inc.·20241126

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061190.

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