Sysing and Hemoglobin Reagent

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K780829 ↗

FDA Product Code

GKR

Device Class

Class II

Regulation

21 CFR Part 864.5620

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Ultra Zyme Plus Ck-1 #64978, 65027 & 28

  Class II

  FDA 510(k) K812593 Active Cleared 2 Oct 1981

• Ultrachem Phosphorus, 64973

  Class I

  FDA 510(k) K772156 Active Cleared 6 Dec 1977

• Ultrachem Total Protein, #64974

  Class II

  FDA 510(k) K772155 Active Cleared 6 Dec 1977

• Ultrazyme Plus Alp

  Class II

  FDA 510(k) K770870 Active Cleared 14 Jul 1977

• Ultra Zyme Plus Gpt, #64956, 65035 & 36

  Class I

  FDA 510(k) K812591 Active Cleared 24 Sep 1981

• Ultrazyme Alkaline Phosphatase

  Class II

  FDA 510(k) K760024 Active Cleared 26 Aug 1976

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• What is the intended use of the SYSING AND HEMOGLOBIN REAGENT?

  The SYSING AND HEMOGLOBIN REAGENT is intended for the automated measurement of hemoglobin levels in blood samples when used with automated hematology analyzers. It functions as a reagent system designed to enable quantitative hemoglobin analysis in clinical laboratory settings, supporting diagnostic evaluation of blood oxygen-carrying capacity.

• How is the SYSING AND HEMOGLOBIN REAGENT supplied and what is its regulatory classification?

  The device is supplied as a reagent system for use with automated hematology analyzers. It is classified as a Class II medical device under regulation 864.5620, with product code GKR, and received FDA 510(k) clearance (K780829) on June 22, 1978, based on substantial equivalence to a legally marketed predicate device.

• What regulatory pathway was used for the SYSING AND HEMOGLOBIN REAGENT, and what does the clearance number indicate?

  The SYSING AND HEMOGLOBIN REAGENT received clearance through the FDA 510(k) pathway, specifically a traditional 510(k) submission (K780829), which was granted on June 22, 1978. The K-number identifies the specific submission and confirms the device was found substantially equivalent to a legally marketed device at the time of clearance.