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Quanticel Hhr, L531 and L532

by Bhp Diagnostix, Inc.

510(k) K781745

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 NumberK781745 Date15 Nov 1978ClearedStatusActive

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  • Withdrawn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
JPK
Device Class
Class II
Regulation
21 CFR Part 864.8625
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.

This device is a Mixture, Hematology Quality Control product, as defined in the device type and nomenclature authority. It is intended for use in hematology quality control procedures.

The device received FDA 510(k) clearance under K-number K781745 on November 15, 1978, and is classified as a Class II medical device. It is manufactured by Bhp Diagnostix, Inc. and is supplied for use in laboratory settings as a reference material for hematology testing.

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Questions

AI-generated answers, 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.

  • What is the QUANTICEL HHR, L531 and L532 device intended for?

    The QUANTICEL HHR, L531 and L532 is a hematology quality control product intended for use in hematology quality control procedures as a reference material in laboratory settings, as specified in its device description and nomenclature classification.

  • How is the QUANTICEL HHR, L531 and L532 supplied and for what setting is it designed?

    The device is supplied for use in laboratory settings as a reference material for hematology testing, manufactured by Bhp Diagnostix, Inc., and intended for laboratory-based quality control procedures.

  • What regulatory pathway was used for the QUANTICEL HHR, L531 and L532, and what is its classification?

    The device received FDA 510(k) clearance under K-number K781745 on November 15, 1978, and is classified as a Class II medical device based on its substantially equivalent decision under the traditional clearance pathway.

  • What product code and advisory committee are associated with the QUANTICEL HHR, L531 and L532?

    The device is assigned product code JPK and was reviewed by the Hematology (HE) advisory committee, as indicated in its regulatory submission data.