FDA device listing

Microplate Reader

FDA device listing 1276569039 · Shanghai Kehua Laboratory System Co., Ltd.

Key facts

Proprietary names Microplate Reader
Owner/operator Shanghai Kehua Laboratory System Co., Ltd.
Owner/operator number 10089305
Product codes JJQ
Device names JJQ - Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device class Class I
Classification regulations (21 CFR) 862.2300
Review panels Clinical Chemistry
Registered establishments SHANGHAI KEHUA LABORATORY SYSTEM CO., LTD.
Establishment registrations 3030234142
FEI numbers 3030234142
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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