Hycel Counter 333

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K782100 ↗

FDA Product Code

GKL

Device Class

Class II

Regulation

21 CFR Part 864.5200

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Albumin Test, Hma Albumin Test

  Class II

  FDA 510(k) K771259 Active Cleared 22 Aug 1977

• Hycel Trigyceride II Test

  Not classified

  FDA 510(k) K802422 Active Cleared 6 Oct 1980

• Creatinine Test, Super Seventeen

  Class II

  FDA 510(k) K770643 Active Cleared 24 Jun 1977

• Propane, High Purity, Instrument Grade

  Class I

  FDA 510(k) K770393 Active Cleared 26 Apr 1977

• Royco Model 970 Hematology Data Analyzer

  Class II

  FDA 510(k) K780946 Active Cleared 27 Jul 1978

• Hma Uric Acid Test

  Class I

  FDA 510(k) K781004 Active Cleared 27 Jul 1978

See all devices from Hycel, Inc. →

• What is the HYCEL COUNTER 333 used for?

  The HYCEL COUNTER 333 is an automated cell counter specifically designed for hematology applications. It counts cells and particles in laboratory samples, providing accurate results for laboratory testing.

• How is the HYCEL COUNTER 333 supplied?

  The HYCEL COUNTER 333 is supplied by Hycel, Inc. It is a Class II medical device that comes with the necessary components for automated cell counting in laboratory settings.

• What is the regulatory status of the HYCEL COUNTER 333?

  The HYCEL COUNTER 333 has FDA 510(k) clearance with product code GKL and regulation number 864.5200. It is classified as substantially equivalent and reviewed under the Hematology advisory committee.

• Is the HYCEL COUNTER 333 reusable or single-use?

  The device description does not specify whether the HYCEL COUNTER 333 is reusable or single-use. For specific usage instructions and disposal guidelines, please refer to the manufacturer's documentation or contact Hycel, Inc. directly.