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Calcium Chloride

FDA 510(k)

Class II (US FDA 510(k))

510(k) K853246

by Bio/Data Corp.

Identifiers

510(k) Number
K853246 FDA 510(k)
FDA Product Code
JPA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.5425 FDA 510(k)
Regulation Number
864.5425 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Calcium Chloride is a multipurpose system used for in vitro coagulation studies. It is designed to function as a reagent in laboratory test procedures requiring specific volumes of calcium chloride.

This device is supplied in specialized packaging to accommodate various instrument volume requirements. It has received FDA 510(k) clearance under regulation number 864.5425.

Frequently asked questions

What is the primary use of this Calcium Chloride system?

This device is a multipurpose reagent system specifically designed for use in laboratory test procedures that require calcium chloride for in vitro coagulation studies.

How is the Calcium Chloride reagent supplied?

The device is supplied in specialized packaging that is designed to accommodate the various volume requirements of different laboratory instruments.

What is the regulatory status of this device?

This device has received FDA 510(k) clearance under regulation number 864.5425, which classifies it as a system for in vitro coagulation studies.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CALCIUM CHLORIDE SOLUTION - Bio/Data Corporation, PDF SAFETY DATA SHEET - Bio/Data Corp, Calcium Chloride Solution — Bio/Data Corporation SDS & Risk Assessment ..., CALCIUM CHLORIDE (0.025M) (K761176) — FDA 510(k) | Innolitics, PDF SAFETY DATA SHEET - Bio/Data Corp

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bio/Data Corp.

Sources (1)

  • FDA 510(k) K853246 24 fields · synced Sep 25, 2026