Tsh-Squibb Radioimmunoassay Kit

FDA 510(k) K821174 · Squibb & Sons, Inc.

Substantially Equivalent

510(k) numberK821174

Submission

Device name
Tsh-Squibb Radioimmunoassay Kit
Applicant
Squibb & Sons, Inc.
Mchenry, IL, US
Received
April 26, 1982
Decision date
May 14, 1982
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 Tsh-Squibb Radioimmunoassay Kit cleared by the FDA?

Tsh-Squibb Radioimmunoassay Kit (K821174) received a 510(k) decision of Substantially Equivalent on May 14, 1982, 18 days after the submission was received.

What is the product code of K821174?

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