RABBIT ANTIBODY TO DIGOXIN— 510(k) K780316

Substantially Equivalent

Pcl-Ria, Inc.

FDA 510(k) clearance K780316 for RABBIT ANTIBODY TO DIGOXIN, Substantially Equivalent on 1978-03-17. Applicant: Pcl-Ria, Inc.. Device class: 2.

Clearance details

Applicant: Pcl-Ria, Inc.
Product code: Code DKA
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1978-02-24
Decision date: 1978-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DKA

K934003 — STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY1994-11-22
K780498 — CBR-DIGOXIN ANTISERUM1978-04-05

More clearances from Pcl-Ria, Inc.

K830526 — B-GCG SYSTEM BY RIA1983-04-05
K822935 — THYROID STIMULATING HORMONE1982-11-01
K823014 — DIGOXIN KIT1982-11-01
K822612 — T3 UPTAKE KITS1982-09-30
K820886 — THYROXINE T4 KIT1982-04-16

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