Endab Digitoxin Enzyme Immunoassay Kit

FDA 510(k) K802461 · Immunotech Corp.

Substantially Equivalent

510(k) numberK802461

Submission

Device name
Endab Digitoxin Enzyme Immunoassay Kit
Applicant
Immunotech Corp.
Walker, MI, US
Received
October 8, 1980
Decision date
October 31, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LCW – Radioimmunoassay, Digitoxin (125-I)
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3300
Specialty
Clinical Toxicology

Other 510(k)s with product code LCW

510(k)DeviceApplicantDecision
K834080Matched Component Set for DigitoxinLCW · Traditional Cambridge Medical Technology02/04/1984SE
K780766(125 I) Digitoxin Ria KitLCW · Traditional Diagnostic Products Corp.07/27/1978SE

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Questions and answers

When was Endab Digitoxin Enzyme Immunoassay Kit cleared by the FDA?

Endab Digitoxin Enzyme Immunoassay Kit (K802461) received a 510(k) decision of Substantially Equivalent on October 31, 1980, 23 days after the submission was received.

What is the product code of K802461?

The FDA product code is LCW – Radioimmunoassay, Digitoxin (125-I), a Class II (moderate risk) device regulated under 21 CFR 862.3300.