ORIGEN ANALYZER

• K Number: K962166
• Device Name: ORIGEN ANALYZER
• Manufacturer: IGEN, INC.
• Date Cleared: 1996-07-31 ( 57 days)
• Product Code: JJQ
• Regulation Number: 862.2300

Intended Use

Get notified when PDF is available

Device Description

Get notified when PDF is available

Predicate Devices

N/A

Reference Devices

N/A

AI/ML (Artificial Intelligence / Machine Learning)

N/A

Therapeutic

N/A

Diagnostic

N/A

SaMD (Software as a Medical Device)

N/A

IVD (In Vitro Diagnostic)

N/A

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

N/A

Regulation Number and Section

§ 862.2300 Colorimeter, photometer, or spectrophotometer for clinical use.

(a)
Identification. A colorimeter, a photometer, or a spectrophotometer for clinical use is an instrument intended to measure radiant energy emitted, transmitted, absorbed, or reflected under controlled conditions. The device may include a monochromator to produce light of a specific wavelength.(b)
Classification. 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.

Summary

N/A