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Phoenix Diagnostics, Inc. 16-201

by Phoenix Diagnostics, Inc.

Phoenix Diagnostics, Inc. 16-201 is a Class I device made by Phoenix Diagnostics, Inc., cleared under FDA 510(k) K013451 on 18 Dec 2001 and listed in FDA GUDID since 26 Jan 2018 (UDI-DI 00853366007158), 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) K013451

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 Number00853366007158 UDI-DI Date26 Jan 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK013451 Date18 Dec 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K013451 decided 18 Dec 2001 Active
  • FDA GUDID UDI-DI 00853366007158 listed 26 Jan 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K013451
  2. Listed FDA GUDID 00853366007158

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  • Withdrawn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
Buffered sample diluent IVD
Model / reference
16-201
Primary DI / UDI-DI
00853366007158
510(k) Number
FDA product code
PPM
GMDN term
Buffered sample diluent IVD
Device class
Class I
Regulation number
864.4010
GUDID distribution status
In Commercial Distribution

Related devices

Category: Buffered sample diluent IVD

Cleared under the same submission (K013451)

and 8 more cleared under K013451

Similar devices in this category

Other devices filed under Buffered sample diluent IVD.

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)