CALCITONIN RADIOIMMUNOASSAY KIT— 510(k) K842907

Name: FDA 510(k) clearance K842907
Creator: U.S. Food and Drug Administration
Published: 1984-09-05

Substantially Equivalent

Nichols Institute Diagnostics

FDA 510(k) clearance K842907 for CALCITONIN RADIOIMMUNOASSAY KIT, Substantially Equivalent on 1984-09-05. Applicant: Nichols Institute Diagnostics. Device class: 2.

Clearance details

Applicant: Nichols Institute Diagnostics
Product code: Code JKR
Device class: Class 2
Regulation: 21 CFR 862.1140
Advisory panel: Clinical Chemistry
Date received: 1984-07-24
Decision date: 1984-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JKR

view all

K252431 — Elecsys Calcitonin2026-04-24
K182012 — ADVIA Centaur Calcitonin (CALCT) assay2018-12-21
K132828 — ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 32013-12-04
K060578 — CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)2006-08-30
K023304 — IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL2002-12-09

More clearances from Nichols Institute Diagnostics

view all

K050784 — NICHOLS ADVANTAGE ALDOSTERONE ASSAY2005-06-01
K042676 — NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY2004-12-17
K042689 — NICHOLS ADVANTAGE CORTISOL2004-12-09
K040813 — NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-70222004-06-08
K033727 — NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY2004-04-22

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