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Multistat Iii Calcium Test

by Instrumentation Laboratory CO

510(k) K771468

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK771468 Date12 Sep 1977ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
CIA
Device class
Class II
Regulation
21 CFR Part 862.1145
Advisory committee
Clinical Chemistry
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Multistat Iii Calcium Test is a device used to measure the total calcium level in serum, classified as Methylthymol Blue, Calcium. It is a calcium test system, and its medical specialty description is Clinical Chemistry.

The device is supplied with a product code of CIA and is classified as a Class II device with special controls. It was cleared by the FDA on September 12, 1977, with a substantially equivalent decision, and has an FDA 510K clearance with the number K771468.

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Questions

AI-generated answers, 25 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 Multistat III Calcium Test used for?

    The Multistat III Calcium Test is used to measure the total calcium level in serum, which is useful in clinical chemistry applications.

  • Is the Multistat III Calcium Test a single-use device?

    The device data does not specify whether the Multistat III Calcium Test is single-use or reusable, but it is supplied with a specific product code and classification.

  • What is the regulatory status of the Multistat III Calcium Test?

    The Multistat III Calcium Test has an FDA 510K clearance with the number K771468, indicating that it has been cleared by the FDA as substantially equivalent to a predicate device.

  • What medical specialty is the Multistat III Calcium Test associated with?

    The Multistat III Calcium Test is associated with the medical specialty of Clinical Chemistry, as indicated by its classification and product code.