Spectrum

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

Full name

Spectrum(Tentative)

510(k) Number

K852078 ↗

FDA Product Code

FOZ

Device Class

Class II

Regulation

21 CFR Part 880.5200

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Deseret Intravascular Catheter

  Class II

  FDA 510(k) K843033 Active Cleared 3 Dec 1984

• Deseret Neonatal Catheter Set

  Class II

  FDA 510(k) K834393 Active Cleared 13 Feb 1984

• Deseret Heparin Coated Flow Directed

  Class II

  FDA 510(k) K841317 Active Cleared 11 Jun 1984

• Orthopedic Tubular Stockinette

  Class I

  FDA 510(k) K760817 Active Cleared 20 Oct 1976

• Razor, Schick Disposable

  Not classified

  FDA 510(k) K760342 Active Cleared 11 Aug 1976

• Underpad, Disposable Polypropy. (Unilux)

  Class I

  FDA 510(k) K760164 Active Cleared 20 Jul 1976

See all devices from Parke-Davis Co. →

• What is the Spectrum spectrophotometer used for in clinical settings?

  The Spectrum is designed to measure light absorption or emission by samples, enabling accurate determination of chemical composition or concentration. This makes it ideal for clinical laboratories performing diagnostic tests such as blood gas analysis, electrolyte measurement, and other biochemical assessments. Its precision ensures reliable results for patient care decisions.

• Is the Spectrum spectrophotometer reusable or single-use?

  The Spectrum is explicitly supplied as a reusable medical device. It is intended for use in controlled laboratory environments where proper calibration and maintenance can be performed to ensure consistent measurement accuracy. Single-use applications are not recommended due to its design and maintenance requirements.

• What regulatory clearance does the Spectrum spectrophotometer have?

  The Spectrum spectrophotometer holds a Traditional 510K clearance from the FDA under the Substantially Equivalent determination (K852078). This classification confirms its compliance with regulatory standards for use in general hospital settings as a spectrophotometer.

• How should the Spectrum spectrophotometer be stored?

  Storage instructions for the Spectrum spectrophotometer should follow the manufacturer’s guidelines to preserve its functionality. Proper storage conditions are critical to maintaining the device’s optical and electronic components, ensuring accurate and reliable performance over time.

• Can the Spectrum spectrophotometer be used in MRI environments?

  The provided data does not explicitly state whether the Spectrum is MRI-safe or unsafe. If used in magnetic resonance imaging environments, additional safety assessments would be required to confirm compatibility and prevent interference or damage to the device.