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UA-Cellular for UF 213465

by Streck

UA-Cellular for UF 213465 is a Class II device made by Streck, cleared under FDA 510(k) K090201 on 27 Mar 2009 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00844509001997), 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) K090201

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 Number00844509001997 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK090201 Date27 Mar 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K090201 decided 27 Mar 2009 Active
  • FDA GUDID UDI-DI 00844509001997 listed 19 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K090201
  2. Listed FDA GUDID 00844509001997

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
UA-Cellular for UF
Generic name
Urine sediment IVD, control
Model / Ref / Catalog
213465
Description
Urinalysis control designed specifically for the Sysmex® UF-1000i™ urine analyzer. Contains 1 vial each of Level 1 & 2.
Primary DI / UDI-DI
00844509001997
510(k) Number
FDA product code
JPK
GMDN term
Urine sediment IVD, control
Device class
Class II
Regulation number
864.8625
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 45 Milliliter

Related devices

Category: Urine sediment IVD, control

Cleared under the same submission (K090201)

Similar devices

Also classified as Urine sediment IVD, control.

Similar devices

Other devices filed under FDA product code JPK (Mixture, Hematology Quality Control).

Other devices from Streck

See all devices from Streck →

Properties

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