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Alko Slope Thb Solution For Corning 280, 288 And 2500 Analyzers

by Alko Diagnostic Corp.

510(k) K951071

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 NumberK951071 Date24 Jul 1995ClearedStatusActive

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  • Withdrawn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
KRZ
Device Class
Class II
Regulation
21 CFR Part 864.8165
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Alko Slope Thb Solution For Corning 280, 288 And 2500 Analyzers is a calibrator for hemoglobin and hematocrit measurement, classified as a device for hematology. It is designed for use with Corning 280, 288, and 2500 analyzers. The device is used in the field of hematology. It is a type of calibrator, specifically for hemoglobin and hematocrit measurement.

The Alko Slope Thb Solution For Corning 280, 288 And 2500 Analyzers is supplied by Alko Diagnostic Corp. It has been cleared under FDA 510(k) with the k-number K951071. The device is classified as a Class II device, with a regulation number of 864.8165. It is used in hematology and has a product code of KRZ.

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Questions

AI-generated answers, 22 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 Alko Slope Thb Solution used for?

    The Alko Slope Thb Solution is used as a calibrator for hemoglobin and hematocrit measurement in the field of hematology.

  • Which analyzers is the Alko Slope Thb Solution compatible with?

    The Alko Slope Thb Solution is designed for use with Corning 280, 288, and 2500 analyzers.

  • What is the regulatory classification of the Alko Slope Thb Solution?

    The Alko Slope Thb Solution is classified as a Class II device with a regulation number of 864.8165.