Data / Medical devices / Enzyme Controls (Assayed And Unassayed) / United States
FDA-registered makers of Enzyme Controls (Assayed And Unassayed) in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Enzyme Controls (Assayed And Unassayed) (product code JJT). 7 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Enzyme Controls (Assayed And Unassayed)
- Product code
- JJT
- Country
- United States
Makers of Enzyme Controls (Assayed And Unassayed) in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Astoria-Pacific, Inc. | Clackamas, OR, United States | Manufacturer | 1 | December 14, 2009 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories Inc. | Irvine, CA, United States | Manufacturer | 1 | August 23, 1990 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories Inc. | Irvine, CA, United States | Manufacturer | 1 | August 23, 1990 | 0 | 0 | 0 | api.fda.gov |
| Cliniqa Corporation | San Marcos, CA, United States | Manufacturer | 1 | March 21, 2003 | 0 | 0 | 0 | api.fda.gov |
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer | 1 | July 22, 1982 | 0 | 0 | 0 | api.fda.gov |
| More Diagnostics Inc. | Los Osos, CA, United States | Manufacturer | 1 | August 29, 1997 | 0 | 0 | 0 | api.fda.gov |
| Verichem Laboratories, Inc. | Providence, RI, United States | Manufacturer | 1 | February 18, 1988 | 0 | 0 | 0 | api.fda.gov |
| Aalto Scientific Ltd. | Eatonton, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alere San Diego, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diazyme Laboratories, Inc. | Poway, CA, United States | Manufacturer | 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.