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Phoenix Diagnostics, Inc. 19-006

by Phoenix Diagnostics, Inc.

Phoenix Diagnostics, Inc. 19-006 is a Class II device made by Phoenix Diagnostics, Inc., cleared under FDA 510(k) K012987 on 7 Nov 2001 and listed in FDA GUDID since 15 Feb 2018 (UDI-DI 00853366007585), 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) K012987

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 Number00853366007585 UDI-DI Date15 Feb 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK012987 Date7 Nov 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K012987 decided 7 Nov 2001 Active
  • FDA GUDID UDI-DI 00853366007585 listed 15 Feb 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K012987
  2. Listed FDA GUDID 00853366007585

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  • Withdrawn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
Multiple electrolyte IVD, calibrator
Model / reference
19-006
Primary DI / UDI-DI
00853366007585
510(k) Number
FDA product code
JIX
GMDN term
Multiple electrolyte IVD, calibrator
Device class
Class II
Regulation number
862.1150
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple electrolyte IVD, calibrator

Cleared under the same submission (K012987)

Other devices from Phoenix Diagnostics, Inc.

See all devices from Phoenix Diagnostics, Inc. →

Properties

  • Lot / batch number
  • Expiration date
Other properties (13, all answered No)