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EZ-Chek K100-0111

by Reprocessing Products Corp

EZ-Chek K100-0111 is a Class II device made by Reprocessing Products Corp, cleared under FDA 510(k) K132344 on 25 Feb 2014 and listed in FDA GUDID since 19 Jan 2017 (UDI-DI 00858293006106), 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

510(k) K132344

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00858293006106 UDI-DI Date19 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK132344 Date25 Feb 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K132344 decided 25 Feb 2014 Active
  • FDA GUDID UDI-DI 00858293006106 listed 19 Jan 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K132344
  2. Listed FDA GUDID 00858293006106

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  • Withdrawn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
K100-0111
Primary DI / UDI-DI
00858293006106
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

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)