MODIFICATION TO RAICHEM CALCIUM REAGENT

• K Number: K022049
• Device Name: MODIFICATION TO RAICHEM CALCIUM REAGENT
• Manufacturer: HEMAGEN DIAGNOSTICS, INC.
• Date Cleared: 2002-07-19 ( 25 days)
• Product Code: CJY
• Regulation Number: 862.1145
• Type: Special
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

RAICHEM® Calcium Reagent ia an in vitro diagnostic intended to measure the calcium level in serum and heparinized plasma. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetani (intermittent muscular contractions or spasms).

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for the Raichem® Calcium Reagent. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document only confirms that the device is substantially equivalent to a legally marketed predicate device for its stated indications for use. Therefore, I cannot provide the requested information based on the provided text.

Regulation Number and Section

§ 862.1145 Calcium test system.

(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.