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Paramax Calcium Reagent

by Baxter Healthcare Corp

510(k) K873519

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK873519 Date14 Dec 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
CIC
Device class
Class II
Regulation
21 CFR Part 862.1145
Advisory committee
Clinical Chemistry
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Paramax Calcium Reagent is a chemical reagent used as a Cresolphthalein Complexone Calcium Test System, classified under product code CIC. It is designed to measure total calcium levels in serum samples, a critical parameter in clinical chemistry for assessing metabolic and bone health.

This reagent is supplied as a single-use diagnostic aid for in vitro laboratory testing, requiring no special storage conditions beyond standard reagent handling. It is regulated under FDA 510(k) clearance (K873519) and falls under Class II with Special Controls, adhering to regulatory standards for clinical chemistry devices. No MRI safety or sterility claims are specified in the data.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Paramax Calcium Reagent used for in a clinical setting?

    The Paramax Calcium Reagent is a diagnostic aid designed specifically for measuring total calcium levels in serum samples. This test is essential in clinical chemistry for evaluating metabolic health, bone disorders, and other conditions where calcium balance is critical.

  • Is the Paramax Calcium Reagent intended for single-use or repeated use?

    The Paramax Calcium Reagent is supplied as a single-use diagnostic aid, meaning each vial or unit is intended for one-time use in laboratory testing. This ensures accuracy and avoids cross-contamination.

  • What storage conditions are required for the Paramax Calcium Reagent?

    No special storage conditions are required beyond standard reagent handling. It can be stored under typical laboratory conditions, as long as it is kept protected from extreme temperatures, moisture, and contamination.

  • How is the regulatory status of the Paramax Calcium Reagent determined?

    The Paramax Calcium Reagent is classified under FDA 510(k) clearance (K873519) and falls under Class II with Special Controls. This means it has been determined to be substantially equivalent to a predicate device and adheres to regulatory standards for clinical chemistry devices, ensuring its safety and effectiveness for measuring calcium levels.