Nova I Fluids Pack

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K820701 ↗

FDA Product Code

JIX

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K850333 Active Cleared 27 Feb 1985

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  FDA 510(k) K830588 Active Cleared 27 Apr 1983

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  FDA 510(k) K833804 Active Cleared 13 Jan 1984

• External Standards-Sodiumnpotassium

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  FDA 510(k) K820700 Active Cleared 1 Apr 1982

See all devices from Shaban Mfg. Co. →

• What is the Nova I Fluids Pack used for in a clinical chemistry lab?

  The Nova I Fluids Pack is a multi-analyte calibrator designed specifically for calibrating automated clinical chemistry analyzers. It provides standardized reference values for multiple analytes, ensuring accurate and consistent test results across laboratory testing. This helps maintain precision in measurements like electrolytes, enzymes, or other biochemical markers.

• Is the Nova I Fluids Pack sterile, and how should it be handled?

  The Nova I Fluids Pack is non-sterile and supplied as a single-use reagent pack. Since it is not sterile, it should be handled using standard laboratory aseptic techniques to prevent contamination. Always follow manufacturer guidelines for preparation and use to ensure reliable calibration.

• How was the Nova I Fluids Pack approved by the FDA, and what does that mean for its use?

  The Nova I Fluids Pack received FDA 510(k) clearance (K820701) through the Traditional pathway in 1982, with a determination of substantial equivalence to a predicate device. This means the FDA reviewed it against an existing approved calibrator and confirmed it meets safety and performance standards for clinical chemistry applications. The clearance does not imply its use for any specific medical condition but confirms its suitability for calibrating automated analyzers.

• Are there different sizes or models of the Nova I Fluids Pack, and how do I identify the correct one?

  The provided data does not specify distinct sizes or models beyond the Nova I Fluids Pack designation. However, the product code (JIX) and registration numbers (e.g., 2030861) may help identify the correct version when ordering. Always verify compatibility with your analyzer system and consult the manufacturer’s documentation or support for exact specifications.

• What storage conditions should I follow for the Nova I Fluids Pack?

  The data does not detail specific storage conditions (e.g., temperature, humidity) for the Nova I Fluids Pack. As a general practice for calibrators, store it in a cool, dry place, away from direct sunlight or extreme temperatures. Check the manufacturer’s instructions or packaging for any additional storage requirements to maintain stability and accuracy.