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EZ-Chek K100-0101B

by Reprocessing Products Corp

EZ-Chek K100-0101B is a Class II device made by Reprocessing Products Corp, cleared under FDA 510(k) K222167 on 18 Oct 2022 (1 earlier submission) and listed in FDA GUDID since 7 Mar 2017 (UDI-DI 00858293006328), active as of 22 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 22 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK222167 Date18 Oct 2022DecidedStatusActive
United StatesGUDID listing Number00858293006328 UDI-DI Date7 Mar 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K222167 decided 18 Oct 2022 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00858293006328 listed 7 Mar 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K901734
  2. Listed FDA GUDID 00858293006328
  3. Cleared FDA 510(k) K222167

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EZ-Chek
Generic name
Haemodialysis equipment residual chlorine test strip
Model / Ref / Catalog
K100-0101B
Primary DI / UDI-DI
00858293006328
510(k) Number
FDA product code
MSY
GMDN term
Haemodialysis equipment residual chlorine test strip
Device class
Class II
Regulation number
876.5665
GUDID distribution status
In Commercial Distribution

Related devices

Category: Haemodialysis equipment residual chlorine test strip

Cleared under the same submission (K901734)

Similar devices

Other devices filed under FDA product code MSY (Strip, Test, Reagent, Residuals For Dialysate, Disinfectant).

Other devices from Reprocessing Products Corp

See all devices from Reprocessing Products Corp →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)