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WaterCheck2 CM20201

by Ibt Scientific LLC

WaterCheck2 CM20201 is a Class II device made by Ibt Scientific LLC, cleared under FDA 510(k) K953854 on 11 Mar 1996 and listed in FDA GUDID since 6 Jan 2022 (UDI-DI G212CM20201), active as of 8 Nov 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 8 Nov 2026

Documents

510(k) K953854

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberG212CM20201 UDI-DI Date6 Jan 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK953854 Date11 Mar 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K953854 decided 11 Mar 1996 Active
  • FDA GUDID UDI-DI G212CM20201 listed 6 Jan 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K953854
  2. Listed FDA GUDID G212CM20201

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
WaterCheck2
Generic name
Haemodialysis equipment residual chlorine test strip
Model / reference
CM20201
Primary DI / UDI-DI
G212CM20201
510(k) Number
FDA product code
FKP
GMDN term
Haemodialysis equipment residual chlorine test strip
Device class
Class II
Regulation number
876.5820
GUDID distribution status
In Commercial Distribution

Related devices

Category: Haemodialysis equipment residual chlorine test strip

Cleared under the same submission (K953854)

Similar devices

Other devices filed under FDA product code FKP (System, Dialysate Delivery, Single Patient).

Other devices from Ibt Scientific LLC

See all devices from Ibt Scientific LLC →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)