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Remel R20304

by Remel, Inc.

Remel R20304 is a Class I device made by Remel, Inc., cleared under FDA 510(k) K834065 on 27 Dec 1983 and listed in FDA GUDID since 22 Dec 2022 (UDI-DI 00848838021886), 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) K834065

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 Number00848838021886 UDI-DI Date22 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK834065 Date27 Dec 1983DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K834065 decided 27 Dec 1983 Active
  • FDA GUDID UDI-DI 00848838021886 listed 22 Dec 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K834065
  2. Listed FDA GUDID 00848838021886

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Remel
Generic name
Microbiological transport medium IVD
Model / Ref / Catalog
R20304
Primary DI / UDI-DI
00848838021886
510(k) Number
FDA product code
JSN
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

Cleared under the same submission (K834065)

Other devices from Remel, Inc.

See all devices from Remel, Inc. →

Properties

  • Lot / batch number
  • Expiration date
Other properties (13, all answered No)