FDA device listing

PHOSPHOURUS (PHOS) (LN 7D71-22, 7D71-31, 7D71-23, 7D71-32)

FDA device listing 1698079165 · ABBOTT LABORATORIES

Key facts

Proprietary names PHOSPHOURUS (PHOS) (LN 7D71-22, 7D71-31, 7D71-23, 7D71-32)
Owner/operator ABBOTT LABORATORIES
Owner/operator number 1415939
Premarket submissions K981759
Product codes CEO
Device names CEO - Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Device class Class I
Classification regulations (21 CFR) 862.1580
Review panels Clinical Chemistry
Registered establishments ABBOTT LABORATORIES
Establishment registrations 3005333358, 3016438761
FEI numbers 3005333358, 3016438761
Establishment operations Complaint File Establishment, Specification Developer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

Browse all FDA device listings