REP 3 FLUR SPE-60 KIT

• K Number: K964453
• Device Name: REP 3 FLUR SPE-60 KIT
• Manufacturer: HELENA LABORATORIES
• Date Cleared: 1996-12-23 ( 47 days)
• Product Code: CEF
• Regulation Number: 862.1630

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

§ 862.1630 Protein (fractionation) test system.

(a)
Identification. A protein (fractionation) test system is a device intended to measure protein fractions in blood, urine, cerebrospinal fluid, and other body fluids. Protein fractionations are used as an aid in recognizing abnormal proteins in body fluids and genetic variants of proteins produced in diseases with tissue destruction.(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