Counter 700 & HC-700 Hemo 0 Ref.

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K771107 ↗

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

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• What clinical setting is the Counter 700 & HC-700 Hemo 0 Ref. designed for, and what types of blood cells does it measure?

  The Counter 700 & HC-700 Hemo 0 Ref. is specifically designed for use in clinical laboratory settings to assist in hematological analysis. It measures and counts red blood cells, white blood cells, and platelets, providing critical data for diagnostic evaluations in hematology.

• Is the Counter 700 & HC-700 Hemo 0 Ref. a single-use or reusable device, and how is it supplied?

  The Counter 700 & HC-700 Hemo 0 Ref. is a reusable instrument, meaning it is built for repeated use in a laboratory environment rather than disposable after a single application. It is supplied as a standalone automated cell counter, not as a consumable or disposable accessory.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

  The Counter 700 & HC-700 Hemo 0 Ref. was cleared through the traditional 510(k) pathway under FDA clearance number K771107, with a substantially equivalent determination. It is classified as Class II with Special Controls and falls under product code GKL, indicating it is subject to additional regulatory oversight beyond general controls.

• Does the Counter 700 & HC-700 Hemo 0 Ref. require any special handling, such as sterility or MRI safety considerations?

  The provided data does not specify any sterility requirements for the Counter 700 & HC-700 Hemo 0 Ref., meaning it is not intended to be sterile or used in sterile procedures. Additionally, no MRI safety information is mentioned, so it should not be used in MRI environments unless explicitly tested and validated for such use elsewhere.