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Phoenix Diagnostics PH5009

by Phoenix Diagnostics, Inc.

Phoenix Diagnostics PH5009 is a multiple clinical chemistry enzyme IVD (FDA Class I; FDA product code JJY, Multi-Analyte Controls, All Kinds (Assayed)) made by Phoenix Diagnostics, Inc., cleared under FDA 510(k) K912718 on 6 Sep 1991 and listed in FDA GUDID since 9 Aug 2023 (UDI-DI 00852676007070), 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) K912718

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 Number00852676007070 UDI-DI Date9 Aug 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK912718 Date6 Sep 1991DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K912718 decided 6 Sep 1991 Active
  • FDA GUDID UDI-DI 00852676007070 listed 9 Aug 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K912718
  2. Listed FDA GUDID 00852676007070

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  • Withdrawn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 clinical chemistry enzyme IVD, control
Model / Ref / Catalog
PH5009
Primary DI / UDI-DI
00852676007070
510(k) Number
FDA product code
JJY
GMDN term
Multiple clinical chemistry enzyme IVD, control
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 5 Milliliter

Related devices

Category: Multiple clinical chemistry enzyme IVD, control

Similar devices

Other devices filed under FDA product code JJY (Multi-Analyte Controls, All Kinds (Assayed)).

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)