FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT— 510(k) K000471

Name: FDA 510(k) clearance K000471
Creator: U.S. Food and Drug Administration
Published: 2000-04-11

Substantially Equivalent

Future Diagnostics B.V.

FDA 510(k) clearance K000471 for FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT, Substantially Equivalent on 2000-04-11. Applicant: Future Diagnostics B.V.. Device class: 2.

Clearance details

Applicant: Future Diagnostics B.V.
Product code: Code CEW
Device class: Class 2
Regulation: 21 CFR 862.1545
Advisory panel: Clinical Chemistry
Date received: 2000-02-14
Decision date: 2000-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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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 Future Diagnostics B.V.

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K002638 — FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT2001-01-17

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 K000471

K-number listed on FDA's recall record

Z-1016-2023 — Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.Class II·Ongoing·Future Diagnostics Solutions B.V.·20221206

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K000471.

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