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Rpc K100-0118BX

by Reprocessing Products Corp

Rpc K100-0118BX is a Class II device made by Reprocessing Products Corp, cleared under FDA 510(k) K090338 on 8 May 2009 and listed in FDA GUDID since 7 Mar 2017 (UDI-DI 00858293006052), 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) K090338

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 Number00858293006052 UDI-DI Date7 Mar 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK090338 Date8 May 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K090338 decided 8 May 2009 Active
  • FDA GUDID UDI-DI 00858293006052 listed 7 Mar 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K090338
  2. Listed FDA GUDID 00858293006052

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Rpc
Generic name
Haemodialysis equipment residual chlorine test strip
Model / Ref / Catalog
K100-0118BX
Primary DI / UDI-DI
00858293006052
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

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)