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Cell-Chex Auto 200068

by Streck

Cell-Chex Auto 200068 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 20844509000567), 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) K053362

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 Number20844509000567 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK053362 Date13 Jan 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K053362 decided 13 Jan 2006 Active
  • FDA GUDID UDI-DI 20844509000567 listed 16 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K053362
  2. Listed FDA GUDID 20844509000567

Coverage

1 jurisdiction

United States of America
  • 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  • Withdrawn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
200068
Primary DI / UDI-DI
20844509000567
510(k) Number
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

Related devices

Category: Full blood count IVD, control

Cleared under the same submission (K053362)

Similar devices in this category

Other devices filed under Full blood count IVD, control.

Other devices from Streck

See all devices from Streck →

Properties

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