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CitoCBC Analyzer 1110

by Cytochip, Inc.

CitoCBC Analyzer 1110 is a Class II device made by Cytochip, Inc., cleared under FDA 510(k) K240402 on 3 Feb 2025 and listed in FDA GUDID since 1 Jul 2025 (UDI-DI 00850063751117), 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) K240402

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 Number00850063751117 UDI-DI Date1 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Dual Track NumberK240402 Date3 Feb 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K240402 decided 3 Feb 2025 Active
  • FDA GUDID UDI-DI 00850063751117 listed 1 Jul 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K240402
  2. Listed FDA GUDID 00850063751117

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CitoCBC Analyzer
Generic name
Haematological cell analyser IVD
Model / reference
1110
Primary DI / UDI-DI
00850063751117
510(k) Number
FDA product code
GKZ
GMDN term
Haematological cell analyser IVD
Device class
Class II
Regulation number
864.5220
GUDID distribution status
In Commercial Distribution

Related devices

Category: Haematological cell analyser IVD

Similar devices in this category

Other devices filed under Haematological cell analyser IVD.

Other devices from Cytochip, Inc.

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)