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Phoenix Diagnostics 3-601

by Phoenix Diagnostics, Inc.

Phoenix Diagnostics 3-601 is a Class II device made by Phoenix Diagnostics, Inc., cleared under FDA 510(k) K902267 on 12 Jun 1990 and listed in FDA GUDID since 13 Aug 2017 (UDI-DI 00852676007773), 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) K902267

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 Number00852676007773 UDI-DI Date13 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK902267 Date12 Jun 1990DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K902267 decided 12 Jun 1990 Active
  • FDA GUDID UDI-DI 00852676007773 listed 13 Aug 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K902267
  2. Listed FDA GUDID 00852676007773

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  • Withdrawn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
Generic name
Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
Model / reference
3-601
Primary DI / UDI-DI
00852676007773
510(k) Number
FDA product code
JIX
GMDN term
Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
Device class
Class II
Regulation number
862.1150
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 460 Milliliter

Related devices

Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator

Cleared under the same submission (K902267)

Similar devices

Other devices filed under FDA product code JIX (Calibrator, Multi-Analyte Mixture).

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)