Data / Medical devices / Catalytic Methods, Amylase

Catalytic Methods, Amylase (JFJ): 27 FDA-registered makers in 10 countries

27 establishments in 10 countries are registered with the FDA to make Catalytic Methods, Amylase (product code JFJ, Class 2, 21 CFR 862.1070). 20 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 99 510(k) clearances under this code, the latest on May 26, 2022, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

JFJ

Device class

2

Regulation

862.1070

Medical specialty

Clinical Chemistry

Makers by country

Makers of Catalytic Methods, Amylase

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated May 26, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.