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Micro-X K100-0100

by Reprocessing Products Corp

Micro-X K100-0100 is a Class II device made by Reprocessing Products Corp, cleared under FDA 510(k) K974064 on 7 Dec 1998 and listed in FDA GUDID since 7 Mar 2017 (UDI-DI 00858293006113), 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) K974064

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 Number00858293006113 UDI-DI Date7 Mar 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK974064 Date7 Dec 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K974064 decided 7 Dec 1998 Active
  • FDA GUDID UDI-DI 00858293006113 listed 7 Mar 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K974064
  2. Listed FDA GUDID 00858293006113

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Micro-X
Generic name
Hydrogen peroxide device disinfectant/sterilant test strip
Model / Ref / Catalog
K100-0100
Primary DI / UDI-DI
00858293006113
510(k) Number
FDA product code
MSY
GMDN term
Hydrogen peroxide device disinfectant/sterilant 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)