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Gradiplasma La High, Gradiplasma La Low Models Lahp-1, Lahp-05, Lalp-1, Lalp-05

by Gradipore, Ltd.

510(k) K993332

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 NumberK993332 Date16 Feb 2000ClearedStatusActive

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  • Withdrawn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
GGC
Models / Variants
FDA applicant
Gradipore , Ltd.
Device Class
Class II
Regulation
21 CFR Part 864.5425
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 device is a Control, Plasma, Abnormal, used in hematology applications. It is a Class 2 medical device with product code GGC and regulation number 864.5425.

The device received FDA 510(k) clearance (K993332) on February 16, 2000, and was found substantially equivalent. It is manufactured by Gradipore, Ltd. and supplied in non-sterile condition for use in laboratory settings.

Other devices from Gradipore, Ltd.

Questions

AI-generated answers, 27 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 GRADIPLASMA LA device used for?

    The GRADIPLASMA LA HIGH and LOW models are used as abnormal plasma controls in hematology applications to verify the accuracy and performance of laboratory testing systems.

  • How is the GRADIPLASMA LA supplied and is it sterile?

    The device is supplied in non-sterile condition for use in laboratory settings, meaning it is not intended for direct patient contact or sterile procedures.

  • What models are included in the GRADIPLASMA LA product line?

    The GRADIPLASMA LA line includes four models: LAHP-1, LAHP-05, LALP-1, and LALP-05, representing high and low abnormal plasma control levels.

  • What regulatory pathway was used for the GRADIPLASMA LA device?

    The device received FDA 510(k) clearance under submission K993332 on February 16, 2000, and was determined to be substantially equivalent to a legally marketed predicate device.