Who is the manufacturer of STRATEC LIA II ANALYZER?

Nichols Institute Diagnostics submitted the Traditional clearance for STRATEC LIA II ANALYZER (K961142).

What is the FDA product code for STRATEC LIA II ANALYZER?

JJE. It is classified under 21 CFR 862.2160 as a Class 1 device in the Clinical Chemistry panel.

What is the regulatory pathway for STRATEC LIA II ANALYZER?

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

STRATEC LIA II ANALYZER

K961142 · Nichols Institute Diagnostics · JJE · Feb 18, 1997 · Clinical Chemistry

Device Facts

Record ID	K961142
Device Name	STRATEC LIA II ANALYZER
Applicant	Nichols Institute Diagnostics
Product Code	JJE · Clinical Chemistry
Decision Date	Feb 18, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.2160
Device Class	Class 1

Regulatory Classification

Identification

A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.