TSH IRMA(125I) Btsi 1(THYROID Stimula-Hormone

FDA 510(k) K851148 · Euro-Diagnostics BV

Substantially Equivalent

510(k) numberK851148

Submission

Device name
TSH IRMA(125I) Btsi 1(THYROID Stimula-Hormone
Applicant
Euro-Diagnostics BV
Old Greenwich, CT, US
Received
March 21, 1985
Decision date
April 29, 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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More from Shenzhen New Industries Biomedical Engineering Co., Ltd.

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Questions and answers

When was TSH IRMA(125I) Btsi 1(THYROID Stimula-Hormone cleared by the FDA?

TSH IRMA(125I) Btsi 1(THYROID Stimula-Hormone (K851148) received a 510(k) decision of Substantially Equivalent on April 29, 1985, 39 days after the submission was received.

What is the product code of K851148?

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