Cell-Chex Auto 200069

Cell-Chex Auto 200069 is a Class II device made by Streck, cleared under FDA 510(k) K053362 on 13 Jan 2006 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 20844509000574), 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	Number20844509000574 UDI-DI	Date16 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK053362	Date13 Jan 2006Decided	StatusActive

Official records

AccessGUDID record UDI-DI 20844509000574
FDA 510(k) database 510(k) number K053362

Across registries

2 registries list this device

FDA 510(k) K053362 decided 13 Jan 2006 Active
FDA GUDID UDI-DI 20844509000574 listed 16 Sep 2016 Listed

Timeline

2 dated events

13 Jan 2006 Cleared FDA 510(k) K053362
16 Sep 2016 Listed FDA GUDID 20844509000574

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Cell-Chex Auto
Generic name: Full blood count IVD, control
Model / Ref / Catalog: 200069

Primary DI / UDI-DI: 20844509000574
510(k) Number: K053362
FDA product code: JPK
GMDN term: Full blood count IVD, control

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

Size: Total Volume — 3.0 Milliliter

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Properties

Convenience kit
Lot / batch number
Expiration date

Other properties (12, all answered No)