FDA device listing

Anaerobic Incubators,Anaerobic Jar,Molecular Biology Instruments

FDA device listing 1569416618 · Infitek Co., Ltd.

Key facts

Proprietary names Anaerobic Incubators,Anaerobic Jar,Molecular Biology Instruments
Owner/operator Infitek Co., Ltd.
Owner/operator number 10088387
Product codes KZJ
Device names KZJ - Device, Gas Generating
Device class Class I
Classification regulations (21 CFR) 866.2580
Review panels Microbiology
Registered establishments INFITEK CO., LTD.
Establishment registrations 3027645317
FEI numbers 3027645317
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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