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TransPRO TPV50

by Hardy Diagnostics

TransPRO TPV50 is a Class I device made by Hardy Diagnostics, cleared under FDA 510(k) K233534 on 2 Aug 2024 and listed in FDA GUDID since 8 Oct 2024 (UDI-DI 00816576026067), active as of 24 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 24 Oct 2026

Documents

510(k) K233534

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816576026067 UDI-DI Date8 Oct 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK233534 Date2 Aug 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K233534 decided 2 Aug 2024 Active
  • FDA GUDID UDI-DI 00816576026067 listed 8 Oct 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K233534
  2. Listed FDA GUDID 00816576026067

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
TransPRO
Generic name
Microbiological transport medium IVD
Model / Ref / Catalog
TPV50
Primary DI / UDI-DI
00816576026067
510(k) Number
FDA product code
JSM
GMDN term
Microbiological transport medium IVD
Device class
Class I
Regulation number
866.2390
GUDID distribution status
In Commercial Distribution

Related devices

Category: Microbiological transport medium IVD

Other devices from Hardy Diagnostics

See all devices from Hardy Diagnostics →

Properties

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