FDA device listing

WowGoHealth Control Solution - GSH-BGM902 - Level 1

FDA device listing 1978674342 · Golden Smart Home Technology Corp.

Key facts

Proprietary names WowGoHealth Control Solution - GSH-BGM902 - Level 1
Owner/operator Golden Smart Home Technology Corp.
Owner/operator number 10060061
Product codes JJX
Device names JJX - Single (Specified) Analyte Controls (Assayed And Unassayed)
Device class Class I
Classification regulations (21 CFR) 862.1660
Review panels Clinical Chemistry
Registered establishments GOLDEN SMART HOME TECHNOLOGY CORP.
Establishment registrations 3015188281
FEI numbers 3015188281
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed 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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