Skip to content

Stat Profile Phox Plus

by Nova Biomedical Corporation 8 variants

Stat Profile Phox Plus (32204) is a Class II device made by Nova Biomedical Corporation, cleared under FDA 510(k) K002613 on 19 Oct 2000 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00385480322041), active as of 23 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 23 Oct 2026

Documents

510(k) K002613

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00385480322041 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK002613 Date19 Oct 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K002613 decided 19 Oct 2000 Active
  • FDA GUDID UDI-DI 00385480322041 listed 20 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K002613
  2. Listed FDA GUDID 00385480322041

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Stat Profile
Generic name
Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Model / Ref / Catalog
PHOX PLUS, 32204
Primary DI / UDI-DI
00385480322041
510(k) Number
FDA product code
JFP, JIX, CGA, CHL, GKR, CEM, CGZ, JPI, GJS
GMDN term
Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Device class
Class II
Regulation number
862.1145, 862.1150, 862.1345, 862.1120, 864.5620, 862.1600, 862.1170, 864.6400, 864.7750
GUDID distribution status
In Commercial Distribution

Related devices

Category: Metabolic profile clinical chemistry analyser IVD, portable, semi-automated

Cleared under the same submission (K002613)

and 8 more cleared under K002613

Similar devices

Other devices filed under FDA product code JFP (ELECTRODE, ION SPECIFIC, CALCIUM).

Other devices from Nova Biomedical Corporation

See all devices from Nova Biomedical Corporation →

Properties

  • Prescription use
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)