STaK-Chex 225514

STaK-Chex 225514 is a Class II device made by Streck, cleared under FDA 510(k) K911582 on 28 May 1991 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 30844509001158), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number30844509001158 UDI-DI	Date19 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK911582	Date28 May 1991Decided	StatusActive

Official records

AccessGUDID record UDI-DI 30844509001158
FDA 510(k) database 510(k) number K911582

Across registries

2 registries list this device

FDA 510(k) K911582 decided 28 May 1991 Active
FDA GUDID UDI-DI 30844509001158 listed 19 Sep 2016 Listed

Timeline

2 dated events

28 May 1991 Cleared FDA 510(k) K911582
19 Sep 2016 Listed FDA GUDID 30844509001158

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: STaK-Chex
Generic name: Full blood count IVD, control
Model / Ref / Catalog: 225514

Primary DI / UDI-DI: 30844509001158
510(k) Number: K911582
FDA product code: JCN
GMDN term: Full blood count IVD, control

Device class: Class II
Regulation number: 864.8625
GUDID distribution status: In Commercial Distribution

Size: Total Volume — 4.0 Milliliter

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Properties

Convenience kit
Lot / batch number
Expiration date

Other properties (12, all answered No)