Skip to content

Calibration Reference Plasma

by Baxter Healthcare Corp

510(k) K874940

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 NumberK874940 Date9 Feb 1988ClearedStatusActive

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  • Withdrawn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
GGP
Device class
Class II
Regulation
21 CFR Part 864.7290
Advisory committee
Hematology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Calibration Reference Plasma is a medical device used for qualitative and quantitative factor deficiency testing in the field of hematology. It is classified as a class 2 device. The device is used as a reference plasma for calibration purposes.

The Calibration Reference Plasma is supplied by Baxter Healthcare Corp and has been cleared by the FDA with a 510(k) clearance (K874940). The device is intended for use in a clinical setting and is regulated under the regulation number 864.7290. It is stored and shipped according to the manufacturer's instructions and is available in various sizes, although specific sizes are not listed.

Other devices from Baxter Healthcare Corp

See all devices from Baxter Healthcare Corp →

Questions

AI-generated answers, 21 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 Calibration Reference Plasma used for?

    The Calibration Reference Plasma is used for qualitative and quantitative factor deficiency testing in the field of hematology, serving as a reference plasma for calibration purposes.

  • How is the Calibration Reference Plasma supplied?

    The device is supplied by Baxter Healthcare Corp and is available in various sizes, although specific sizes are not listed, and is stored and shipped according to the manufacturer's instructions.

  • Is the Calibration Reference Plasma cleared by the FDA?

    Yes, the Calibration Reference Plasma has been cleared by the FDA with a 510(k) clearance, specifically K874940, and is regulated under the regulation number 864.7290.