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RDW and MPV Indices on Hemat 12

by Texas Intl. Laboratories, Inc.

510(k) K900684

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 NumberK900684 Date16 Apr 1990ClearedStatusActive

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  • Withdrawn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
GKZ
Device Class
Class II
Regulation
21 CFR Part 864.5220
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 RDW and MPV Indices on Hemat 12 is a Differential Cell Counter, a device designed to measure red blood cell distribution width (RDW) and mean platelet volume (MPV) from blood samples. It provides quantitative indices to assess red blood cell variability and platelet size distribution, aiding in the evaluation of hematologic conditions.

This device is intended for use in clinical laboratories and is supplied as a reusable instrument. It operates under non-sterile conditions and is not intended for MRI environments. The Hemat 12 system is regulated under FDA 510(k) clearance (K900684) and falls under Class II medical devices (regulation number 864.5220). No specific sterility or single-use requirements are noted in the regulatory data.

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