Stat-Site Mhgb Meter, Stat-Site Mhgb Meter Card Holder, Stat-Site Mhgb Test Cards, Stat-Site Mhgb Code Way, Models 90090

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K020138 ↗

FDA Product Code

KHG

Device Class

Class II

Regulation

21 CFR Part 864.7500

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Glucosite Test System

  Class II

  FDA 510(k) K971145 Active Cleared 17 Sep 1997

• Hemosite Test System

  Class II

  FDA 510(k) K994073 Active Cleared 14 Jan 2000

• Ketosite(Tm)/Stat-Site(Tm)/Ketosite(Tm) Low-Hi Con

  Class I

  FDA 510(k) K911801 Active Cleared 1 Jul 1991

• Cholesite Test System

  Class I

  FDA 510(k) K992132 Active Cleared 20 Aug 1999

• GDS Enzymatic Salicylate Reagent

  Class II

  FDA 510(k) K882038 Active Cleared 24 Jun 1988

• Gds Enzymatic Acetaminophen Reagent

  Class II

  FDA 510(k) K880829 Active Cleared 27 May 1988

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• What is the Stat-Site MHgb Meter system used for?

  This system is an in-vitro diagnostic tool designed for the quantitative determination of hemoglobin levels in whole blood. It is intended to assist clinicians in performing hematological assessments.

• What components are included in the model 90090 system?

  The system is supplied as a complete set of components required for testing, which includes the meter, a card holder, the necessary test cards, and a code key.

• What is the regulatory status of this device?

  The Stat-Site MHgb Meter system has received FDA 510(k) clearance for its intended use as a whole blood hemoglobin determination device, following a determination of substantial equivalence.