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Chemistry Analyzer CLC720i

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06944904084459 UDI-DIDate23 Jan 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
Chemistry Analyzer
Generic Name
Multiple clinical chemistry analyser IVD, laboratory
Model / Reference
CLC720i
Primary DI / UDI-DI
06944904084459
510(k) Number
FDA Product Code
CDQ, JGS, CEM, CGZ, JJE
GMDN Term
Multiple clinical chemistry analyser IVD, laboratory
Device Class
Class II
Regulation Number
862.1770, 862.1665, 862.1600, 862.1170, 862.2160
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K140690)

Other devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

See all devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. →

Properties

  • Serial Number
  • Manufacturing Date

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No