MIN-MOLECULE PTH BY RADIOIMMUNOASSAY— 510(k) K820228

Name: FDA 510(k) clearance K820228
Creator: U.S. Food and Drug Administration
Published: 1982-03-11

Substantially Equivalent

Immuno Nuclear Corp.

FDA 510(k) clearance K820228 for MIN-MOLECULE PTH BY RADIOIMMUNOASSAY, Substantially Equivalent on 1982-03-11. Applicant: Immuno Nuclear Corp.. Device class: 2.

Clearance details

Applicant: Immuno Nuclear Corp.
Product code: Code CEW
Device class: Class 2
Regulation: 21 CFR 862.1545
Advisory panel: Clinical Chemistry
Date received: 1982-01-27
Decision date: 1982-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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 Immuno Nuclear Corp.

view all

K863743 — BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT1986-12-15
K863973 — ELM ALLERGEN DISC1986-12-01
K863844 — IMMUNO BIOTECH'S LAMB'S QUARTERS ALLERGEN DISC1986-10-29
K863123 — IMMUNO BIOTECH MUGWART ALLERGEN DISC1986-10-01
K863098 — MEADOW FESCUE ALLERGEN DISC1986-09-15

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.