FDA device listing

Photometric Method, Iron (Non-Heme)

FDA device listing 1921198931 · SENSOR HEALTH PRODUCTS, INC.

Key facts

Owner/operator SENSOR HEALTH PRODUCTS, INC.
Owner/operator number 9072536
Premarket submissions K924691
Product codes JIY
Device names JIY - Photometric Method, Iron (Non-Heme)
Device class Class I
Classification regulations (21 CFR) 862.1410
Review panels Clinical Chemistry
Registered establishments SENSOR HEALTH PRODUCTS, INC.
Establishment registrations 3004192065
FEI numbers 3004192065
Establishment operations Foreign Exporter
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 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

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