Data / Medical devices / Enzyme Controls (Assayed And Unassayed)
Enzyme Controls (Assayed And Unassayed) (JJT): 15 FDA-registered makers in 6 countries
15 establishments in 6 countries are registered with the FDA to make Enzyme Controls (Assayed And Unassayed) (product code JJT, Class 1, 21 CFR 862.1660). 9 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 97 510(k) clearances under this code, the latest on December 14, 2009, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JJT
- Device class
- 1
- Regulation
- 862.1660
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| Spain | 1 |
| Finland | 1 |
| United Kingdom | 1 |
| Germany | 1 |
| Japan | 1 |
Makers of Enzyme Controls (Assayed And Unassayed)
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Biokit S.A. | LLISSA D AMUNT Barcelona, Spain | Manufacturer | 2 | February 2, 1999 | 0 | 0 | 0 | api.fda.gov |
| 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 |
| Wallac OY | TURKU Varsinais-Suomi, Finland | Complaint file establishment, Manufacturer | 1 | September 21, 1995 | 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 | |
| Randox Laboratories Limited | CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shino-Test Corporation | Sagamihara Kanagawa, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 14, 2009. 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.