Skip to content

Kova 87426

by Kova International Inc

Kova 87426 is a Class I device made by Kova International Inc, cleared under FDA 510(k) K843565 on 5 Oct 1984 and listed in FDA GUDID since 31 Jul 2020 (UDI-DI 00855617006347), active as of 22 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 22 Oct 2026

Documents

510(k) K843565

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00855617006347 UDI-DI Date31 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK843565 Date5 Oct 1984DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K843565 decided 5 Oct 1984 Active
  • FDA GUDID UDI-DI 00855617006347 listed 31 Jul 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K843565
  2. Listed FDA GUDID 00855617006347

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Kova
Generic name
Urine sediment IVD, control
Model / Ref / Catalog
87426
Primary DI / UDI-DI
00855617006347
510(k) Number
FDA product code
JJW
GMDN term
Urine sediment IVD, control
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Urine sediment IVD, control

Cleared under the same submission (K843565)

and 8 more cleared under K843565

Similar devices

Other devices filed under FDA product code JJW (Urinalysis Controls (Assayed And Unassayed)).

Other devices from Kova International Inc

See all devices from Kova International Inc →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)