Beta-Tsh-Irma

FDA 510(k) K853977 · Leeco Diagnostics, Inc.

Substantially Equivalent

510(k) numberK853977

Submission

Device name
Beta-Tsh-Irma
Applicant
Leeco Diagnostics, Inc.
Southfield, MI, US
Received
September 26, 1985
Decision date
October 22, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JLW – Radioimmunoassay, Thyroid-Stimulating Hormone
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1690
Specialty
Clinical Chemistry

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Questions and answers

When was Beta-Tsh-Irma cleared by the FDA?

Beta-Tsh-Irma (K853977) received a 510(k) decision of Substantially Equivalent on October 22, 1985, 26 days after the submission was received.

What is the product code of K853977?

The FDA product code is JLW – Radioimmunoassay, Thyroid-Stimulating Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1690.