DIGOXIN STANDARDS IN HUMAN SERUM— 510(k) K780889

Substantially Equivalent

Pcl-Ria, Inc.

FDA 510(k) clearance K780889 for DIGOXIN STANDARDS IN HUMAN SERUM, Substantially Equivalent on 1978-08-14. Applicant: Pcl-Ria, Inc.. Device class: 1.

Clearance details

Applicant: Pcl-Ria, Inc.
Product code: Code DMP
Device class: Class 1
Regulation: 21 CFR 862.3280
Advisory panel: Clinical Toxicology
Date received: 1978-05-31
Decision date: 1978-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DMP

K973973 — ELECSYS CALLCHECK DIGOXIN1997-11-04
K953393 — TOX PERFECT A TUBE1995-10-06
K770411 — DIGI TROL TM-RX & DIGI TROL TM-TX1977-03-16

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.