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Phoenix Diagnostics, Inc. E-930

by Phoenix Diagnostics, Inc.

Phoenix Diagnostics, Inc. E-930 is a Class I device made by Phoenix Diagnostics, Inc., cleared under FDA 510(k) K020148 on 4 Feb 2002 and listed in FDA GUDID since 26 Jan 2018 (UDI-DI 00853366007134), 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) K020148

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 Number00853366007134 UDI-DI Date26 Jan 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK020148 Date4 Feb 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K020148 decided 4 Feb 2002 Active
  • FDA GUDID UDI-DI 00853366007134 listed 26 Jan 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K020148
  2. Listed FDA GUDID 00853366007134

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Phoenix Diagnostics, Inc.
Generic name
Reference electrode IVD
Model / reference
E-930
Primary DI / UDI-DI
00853366007134
510(k) Number
FDA product code
JJP
GMDN term
Reference electrode IVD
Device class
Class I
Regulation number
862.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Reference electrode IVD

Cleared under the same submission (K020148)

and 6 more cleared under K020148

Other devices from Phoenix Diagnostics, Inc.

See all devices from Phoenix Diagnostics, Inc. →

Properties

  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)