Data / Medical devices / Catalytic Methods, Amylase / United States
FDA-registered makers of Catalytic Methods, Amylase in the United States: 15 establishments
15 establishments in the United States are registered with the FDA to make Catalytic Methods, Amylase (product code JFJ). 12 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- Catalytic Methods, Amylase
- Product code
- JFJ
- Country
- United States
Makers of Catalytic Methods, Amylase in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Teco Diagnostics | Anaheim, CA, United States | Manufacturer | 3 | May 10, 2004 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 2 | October 16, 2009 | 0 | 0 | 0 | api.fda.gov |
| Cliniqa Corporation | San Marcos, CA, United States | Manufacturer | 2 | May 29, 1986 | 0 | 0 | 0 | api.fda.gov |
| Fisher Diagnostics | Middletown, VA, United States | Manufacturer | 2 | May 22, 2007 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 2 | July 30, 2019 | 0 | 0 | 0 | api.fda.gov |
| Abbott Laboratories | Irving, TX, United States | Specification developer | 1 | August 28, 1998 | 0 | 0 | 0 | api.fda.gov |
| Carolina Liquid Chemistries | Brea, CA, United States | Manufacturer | 1 | January 31, 1994 | 0 | 0 | 0 | api.fda.gov |
| Hemagen Diagnostics, Inc. | Baltimore, MD, United States | Manufacturer | 1 | May 15, 1990 | 0 | 0 | 0 | api.fda.gov |
| Infrared Laboratory Systems dba SYNERMED | Westfield, IN, United States | Manufacturer | 1 | May 3, 1994 | 0 | 0 | 0 | api.fda.gov |
| Medica Corp. | Bedford, MA, United States | Manufacturer | 1 | November 17, 2008 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer, Specification developer | 1 | September 9, 1994 | 0 | 0 | 0 | api.fda.gov |
| Stanbio Laboratory | Boerne, TX, United States | Manufacturer | 1 | January 31, 1991 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bialex Lab | Wichita Falls, TX, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Supplies & Technology, Inc. | Doral, FL, United States | Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.