Who is the manufacturer of TSH (MICROWELL) ELISA?

Biomerica, Inc. submitted the Traditional clearance for TSH (MICROWELL) ELISA (K962216).

What is the FDA product code for TSH (MICROWELL) ELISA?

JLW. It is classified under 21 CFR 862.1690 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for TSH (MICROWELL) ELISA?

510(k) clearance (submission type: Traditional).

TSH (MICROWELL) ELISA

K962216 · Biomerica, Inc. · JLW · Sep 19, 1996 · Clinical Chemistry

Device Facts

Record ID	K962216
Device Name	TSH (MICROWELL) ELISA
Applicant	Biomerica, Inc.
Product Code	JLW · Clinical Chemistry
Decision Date	Sep 19, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1690
Device Class	Class 2

Regulatory Classification

Identification

A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.