Sysmex CC-130

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K830505 ↗

FDA Product Code

GKL

Device Class

Class II

Regulation

21 CFR Part 864.5200

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Sysmex K-1000 18 Parameter, Auto. Hema Analyzer

  Class II

  FDA 510(k) K882370 Active Cleared 25 Aug 1988

• Ca-1000 Automated Coagulation Analyzer

  Class II

  FDA 510(k) K931149 Active Cleared 3 Nov 1993

• Sysmex Hematological Whole Blood Diluting Reagent-

  Class I

  FDA 510(k) K850239 Active Cleared 1 Apr 1985

• Microcell Counter Model Cc-108

  Class II

  FDA 510(k) K780224 Active Cleared 19 May 1978

• Sysmex Ne-8000

  Class II

  FDA 510(k) K883997 Active Cleared 5 Dec 1988

• Sysmex Ne-1500, Modification

  Class II

  FDA 510(k) K914744 Active Cleared 30 Dec 1991

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• What is the Sysmex CC-130 used for?

  The Sysmex CC-130 is an automated particle counter used in hematology for counting cells in clinical laboratory settings, as specified in its device description and classification under FDA regulation 864.5200.

• Is the Sysmex CC-130 reusable or single-use?

  The Sysmex CC-130 is supplied as a reusable instrument, meaning it is designed for multiple uses in clinical laboratory environments after appropriate cleaning and maintenance, as stated in the device data.

• How was the Sysmex CC-130 cleared for market?

  The Sysmex CC-130 received traditional 510(k) clearance (K830505) from the FDA on May 9, 1983, demonstrating substantial equivalence to a legally marketed predicate device, which is the regulatory pathway described in the authorization details.