MSI-CAL 16

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K883850 ↗

FDA Product Code

KRZ

Device Class

Class II

Regulation

21 CFR Part 864.8165

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Sgpt Reagent Set

  Class I

  FDA 510(k) K841060 Active Cleared 1 May 1984

• Alkaline Phosphotase Reagent Set

  Class II

  FDA 510(k) K841064 Active Cleared 1 May 1984

• Creatinine Reagent Set

  Class II

  FDA 510(k) K841070 Active Cleared 1 May 1984

• Glucose Enzymatic Reagent Set

  Class II

  FDA 510(k) K841055 Active Cleared 1 May 1984

• Msi-Cal 8

  Class II

  FDA 510(k) K883851 Active Cleared 22 Nov 1988

• Msi-Hct

  Class II

  FDA 510(k) K924926 Active Cleared 7 Jan 1993

See all devices from Medical Specialties, Inc. →

• What is the MSI-CAL 16 used for?

  The MSI-CAL 16 is a calibrator used to ensure accurate calibration of instruments that measure hemoglobin and hematocrit levels in blood samples. It is intended for quality control purposes in clinical laboratory settings to maintain measurement precision.

• Who supplies the MSI-CAL 16?

  The MSI-CAL 16 is supplied by Medical Specialties, Inc., a company based in South Plainfield, New Jersey. The device is distributed through standard medical supply channels for clinical laboratories.

• What regulatory status does the MSI-CAL 16 have?

  The MSI-CAL 16 received 510(k) clearance under number K883850 with a decision of substantial equivalence. It is regulated under FDA class 2 with product code KRZ, indicating it is a moderately complex laboratory device.

• Is the MSI-CAL 16 single-use or reusable?

  The device data does not specify whether the MSI-CAL 16 is single-use or reusable. This information would typically be found in the manufacturer's labeling or instructions for use, which should be consulted for proper handling and disposal procedures.

• What sizes or models are available for the MSI-CAL 16?

  The device data indicates only one model: MSI-CAL 16. No additional sizes, variants, or configurations are listed in the regulatory filing, suggesting this is a single-standard calibrator for hemoglobin and hematocrit measurement systems.