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HQ-Chex 232756

by Streck

HQ-Chex 232756 is a Class I device made by Streck, cleared under FDA 510(k) K933844 on 27 Dec 1993 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00844509001713), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K933844

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00844509001713 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK933844 Date27 Dec 1993DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K933844 decided 27 Dec 1993 Active
  • FDA GUDID UDI-DI 00844509001713 listed 19 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K933844
  2. Listed FDA GUDID 00844509001713

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
HQ-Chex
Generic name
Glucose/haemoglobin (Hb) IVD, control
Model / Ref / Catalog
232756
Description
A whole blood glucose and hemoglobin control designed to evaluate the accuracy and precision of HemoCue® analyzers. Contains 2 vials each of level 1, 2 & 3.
Primary DI / UDI-DI
00844509001713
510(k) Number
FDA product code
JJY
GMDN term
Glucose/haemoglobin (Hb) IVD, control
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 2.5 Milliliter

Related devices

Category: Glucose/haemoglobin (Hb) IVD, control

Cleared under the same submission (K933844)

and 2 more cleared under K933844

Similar devices

Other devices filed under FDA product code JJY (Multi-Analyte Controls, All Kinds (Assayed)).

Other devices from Streck

See all devices from Streck →

Properties

  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)