Bartels B1029-41A

by Clark Laboratories, Inc.

Bartels B1029-41A 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 05391516747325), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number05391516747325 UDI-DI	Date7 May 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK834115	Date23 Mar 1984Decided	StatusActive

Official records

AccessGUDID record UDI-DI 05391516747325
FDA 510(k) database 510(k) number K834115

Across registries

2 registries list this device

FDA 510(k) K834115 decided 23 Mar 1984 Active
FDA GUDID UDI-DI 05391516747325 listed 7 May 2017 Listed

Timeline

2 dated events

23 Mar 1984 Cleared FDA 510(k) K834115
7 May 2017 Listed FDA GUDID 05391516747325

Coverage

1 jurisdiction

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Withdrawn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: B1029-41A

Primary DI / UDI-DI: 05391516747325
510(k) Number: K834115
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

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Other devices from Clark Laboratories, Inc.

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Properties

Lot / batch number
Expiration date

Other properties (13, all answered No)