Fisherbrand 401223FB

by Fisher Scientific Company L.L.C.

Fisherbrand 401223FB is a Class II device made by Fisher Scientific Company L.L.C., cleared under FDA 510(k) K032753 on 18 Nov 2003 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00613647000793), 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	Number00613647000793 UDI-DI	Date24 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK032753	Date18 Nov 2003Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00613647000793
FDA 510(k) database 510(k) number K032753

Across registries

2 registries list this device

FDA 510(k) K032753 decided 18 Nov 2003 Active
FDA GUDID UDI-DI 00613647000793 listed 24 Sep 2016 Listed

Timeline

2 dated events

18 Nov 2003 Cleared FDA 510(k) K032753
24 Sep 2016 Listed FDA GUDID 00613647000793

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Fisherbrand
Generic name: Glucose IVD, reagent
Model / Ref / Catalog: 401223FB

Primary DI / UDI-DI: 00613647000793
510(k) Number: K032753
FDA product code: MRV
GMDN term: Glucose IVD, reagent

Device class: Class II
Regulation number: 862.1345
GUDID distribution status: In Commercial Distribution

Other devices from Fisher Scientific Company L.L.C.

See all devices from Fisher Scientific Company L.L.C. →

Properties

Single use
Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (10, all answered No)