Coat-A-Count Digitoxin Ria Kit

FDA 510(k) K812129 · Diagnostic Products Corp.

Substantially Equivalent

510(k) numberK812129

Submission

Device name
Coat-A-Count Digitoxin Ria Kit
Applicant
Diagnostic Products Corp.
Mchenry, IL, US
Received
July 27, 1981
Decision date
August 13, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DPG – Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3300
Specialty
Clinical Toxicology

Other 510(k)s with product code DPG

510(k)DeviceApplicantDecision
K935229Opus DigitoxinDPG · Traditional Pb Diagnostic Systems, Inc.12/22/1993SE
K780075Rialyze DigoxinDPG · Traditional Miles Laboratories, Inc.02/28/1978SE

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Questions and answers

When was Coat-A-Count Digitoxin Ria Kit cleared by the FDA?

Coat-A-Count Digitoxin Ria Kit (K812129) received a 510(k) decision of Substantially Equivalent on August 13, 1981, 17 days after the submission was received.

What is the product code of K812129?

The FDA product code is DPG – Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep., a Class II (moderate risk) device regulated under 21 CFR 862.3300.