RADIOIMMUNOASSAY PARATHYROID HORMONE MID— 510(k) K821131

Name: FDA 510(k) clearance K821131
Creator: U.S. Food and Drug Administration
Published: 1982-06-02

Substantially Equivalent

Endocrine-Metabolic Center

FDA 510(k) clearance K821131 for RADIOIMMUNOASSAY PARATHYROID HORMONE MID, Substantially Equivalent on 1982-06-02. Applicant: Endocrine-Metabolic Center. Device class: 2.

Clearance details

Applicant: Endocrine-Metabolic Center
Product code: Code CEW
Device class: Class 2
Regulation: 21 CFR 862.1545
Advisory panel: Clinical Chemistry
Date received: 1982-04-20
Decision date: 1982-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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 Endocrine-Metabolic Center

view all

K811993 — RADIOIMMUNOASSAY, FOLLICLE STIMULATING1981-08-03
K811994 — RADIOIMMUNOASSAY LUTEINIZING HORMONE1981-07-27
K810948 — RADIOIMMUNOASSAY THYROID STIM. HORM. KIT1981-04-17
K810351 — RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE1981-02-23
K800187 — EMC-M-175, THYROXINE - 100 TUBES1980-02-13

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 →

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