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Kallestad 29403

by Bio-Rad Laboratories

Kallestad 29403 is a Class II device made by Bio-Rad Laboratories, cleared under FDA 510(k) K982898 on 30 Nov 1998 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00847817016103), 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) K982898

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 Number00847817016103 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK982898 Date30 Nov 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K982898 decided 30 Nov 1998 Active
  • FDA GUDID UDI-DI 00847817016103 listed 12 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K982898
  2. Listed FDA GUDID 00847817016103

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Kallestad
Generic name
Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
Model / Ref / Catalog
29403
Primary DI / UDI-DI
00847817016103
510(k) Number
FDA product code
MOB
GMDN term
Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
Device class
Class II
Regulation number
866.5660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay

Cleared under the same submission (K982898)

and 8 more cleared under K982898

Similar devices in this category

Other devices filed under Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay.

Other devices from Bio-Rad Laboratories

See all devices from Bio-Rad Laboratories →

Properties

  • Single use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)