Rabbit Antibody to Digoxin

FDA 510(k) K780316 · Pcl-Ria, Inc.

Substantially Equivalent

510(k) numberK780316

Submission

Device name
Rabbit Antibody to Digoxin
Applicant
Pcl-Ria, Inc.
Mchenry, IL, US
Received
February 24, 1978
Decision date
March 17, 1978
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DKA – Antiserum, Digoxin
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3320
Specialty
Clinical Toxicology

Other 510(k)s with product code DKA

510(k)DeviceApplicantDecision
K934003Stratus Digoxin Flourometric Enzyme ImmunoassayDKA · Traditional Baxter Diagnostics, Inc.11/22/1994SE
K780498Cbr-Digoxin AntiserumDKA · Traditional Clinical Bioresearch04/05/1978SE

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Questions and answers

When was Rabbit Antibody to Digoxin cleared by the FDA?

Rabbit Antibody to Digoxin (K780316) received a 510(k) decision of Substantially Equivalent on March 17, 1978, 21 days after the submission was received.

What is the product code of K780316?

The FDA product code is DKA – Antiserum, Digoxin, a Class II (moderate risk) device regulated under 21 CFR 862.3320.