Skip to content

Bartels B1029-41

by Clark Laboratories, Inc.

Bartels B1029-41 is a Class I device made by Clark Laboratories, Inc., cleared under FDA 510(k) K834115 on 23 Mar 1984 and listed in FDA GUDID since 7 May 2017 (UDI-DI 05391516747318), 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) K834115

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 Number05391516747318 UDI-DI Date7 May 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK834115 Date23 Mar 1984DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K834115 decided 23 Mar 1984 Active
  • FDA GUDID UDI-DI 05391516747318 listed 7 May 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K834115
  2. Listed FDA GUDID 05391516747318

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Bartels
Generic name
Culture medium antimicrobial supplement IVD
Model / Ref / Catalog
B1029-41
Primary DI / UDI-DI
05391516747318
510(k) Number
FDA product code
JSK
GMDN term
Culture medium antimicrobial supplement IVD
Device class
Class I
Regulation number
866.2450
GUDID distribution status
In Commercial Distribution

Related devices

Category: Culture medium antimicrobial supplement IVD

Cleared under the same submission (K834115)

Other devices from Clark Laboratories, Inc.

See all devices from Clark Laboratories, Inc. →

Properties

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