Total Calcium Reagent Set

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

510(k) Number

K812835 ↗

FDA Product Code

CIC

Device Class

Class II

Regulation

21 CFR Part 862.1145

Advisory Committee

Clinical Chemistry

FDA Decision

SESP Substantially Equivalent — Postmarket Surveillance

• Total & Direct Bilirubin Reagent Set

  Class II

  FDA 510(k) K812841 Active Cleared 27 Nov 1981

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  FDA 510(k) K811764 Active Cleared 20 Aug 1981

• Hemoglobin Reagent

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  FDA 510(k) K821658 Active Cleared 25 Jun 1982

See all devices from Anco Medical Reagents & Assoc. →

• What clinical chemistry method does the Total Calcium Reagent Set use to measure calcium levels in serum or plasma samples?

  The Total Calcium Reagent Set employs the cresolphthalein complexone method, a widely recognized standard in clinical chemistry for quantitatively determining total calcium concentrations in serum or plasma samples. This method is designed for accuracy and reliability in laboratory diagnostics.

• Is this reagent set intended for single-use or repeated use in a clinical setting?

  The Total Calcium Reagent Set is explicitly supplied as a single-use reagent kit, meaning each kit is intended for one-time use in a clinical laboratory. This aligns with standard practices for reagent stability and regulatory requirements for Class 2 devices.

• How is this device authorized for use in the United States, and what regulatory pathway was followed?

  The Total Calcium Reagent Set has been cleared through the FDA’s Traditional 510(k) pathway under product code CIC, which is the standard regulatory route for Class 2 devices in the U.S. This clearance confirms its compliance with FDA requirements for clinical chemistry reagents.

• What type of storage and handling instructions should be followed for this reagent set?

  While specific storage details are not provided in the data, reagent sets like this typically require adherence to standard laboratory protocols for reagent stability, such as refrigeration (if applicable), protection from light, and proper sealing to prevent contamination. Always refer to the manufacturer’s instructions for precise guidance.