21 CFR 862.1780 — Infrared Spectroscopy Measurement, Urinary Calculi (Stone)

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1780

Identification

A urinary calculi (stones) test system is a device intended for the analysis of urinary calculi. Analysis of urinary calculi is used in the diagnosis and treatment of calculi of the urinary tract.

Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

Product Codes

Product CodeDevice NameClassDevicesAttributes
JNPInfrared Spectroscopy Measurement, Urinary Calculi (Stone)10
JNQQualitative Chemical Reactions, Urinary Calculi (Stone)10
Innolitics

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