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Metricide 10-602

by Metrex Research

Metricide 10-602 is a Class II device made by Metrex Research, cleared under FDA 510(k) K070419 on 31 Aug 2007 and listed in FDA GUDID since 24 Oct 2023 (UDI-DI 00615375008577), active as of 23 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 23 Oct 2026

Documents

510(k) K070419

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00615375008577 UDI-DI Date24 Oct 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK070419 Date31 Aug 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K070419 decided 31 Aug 2007 Active
  • FDA GUDID UDI-DI 00615375008577 listed 24 Oct 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K070419
  2. Listed FDA GUDID 00615375008577

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Metricide
Generic name
Ortho-phthalaldehyde (OPA) device disinfectant test strip
Model / reference
10-602
Primary DI / UDI-DI
00615375008577
510(k) Number
FDA product code
JOJ
GMDN term
Ortho-phthalaldehyde (OPA) device disinfectant test strip
Device class
Class II
Regulation number
880.2800
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code JOJ (Indicator, Physical/Chemical Sterilization Process).

Other devices from Metrex Research

See all devices from Metrex Research →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)