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Stat Profile Phox Ultra

by Nova Biomedical Corporation 5 variants

Stat Profile Phox Ultra (48564) is a Class II device made by Nova Biomedical Corporation, cleared under FDA 510(k) K110648 on 29 Aug 2011 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00385480485647), 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) K110648

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 Number00385480485647 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK110648 Date29 Aug 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K110648 decided 29 Aug 2011 Active
  • FDA GUDID UDI-DI 00385480485647 listed 20 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K110648
  2. Listed FDA GUDID 00385480485647

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  • Withdrawn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 ULTRA, 48564
Primary DI / UDI-DI
00385480485647
510(k) Number
FDA product code
GHS, GLY, CFA, JGS, CGA, CHL, CGZ, GJC, JFP, BXX, CDS, CGL, NGD, CEM, JIX, JJB, GGZ, GKK
GMDN term
Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Device class
Class II
Regulation number
864.7425, 864.7500, 862.1495, 862.1665, 862.1345, 862.1120, 862.1170, 864.7490, 862.1145, 868.2620, 862.1770, 862.1225, 862.1450, 862.1600, 862.1150, 862.1115
GUDID distribution status
In Commercial Distribution

Related devices

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

Cleared under the same submission (K110648)

and 8 more cleared under K110648

Similar devices

Other devices filed under FDA product code GHS (ASSAY, CARBOXYHEMOGLOBIN).

Other devices from Nova Biomedical Corporation

See all devices from Nova Biomedical Corporation →

Properties

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