Data / Medical devices / Atp And Creatine Kinase (Enzymatic), Creatine
Atp And Creatine Kinase (Enzymatic), Creatine (JLB): 12 FDA-registered makers in 6 countries
12 establishments in 6 countries are registered with the FDA to make Atp And Creatine Kinase (Enzymatic), Creatine (product code JLB, Class 1, 21 CFR 862.1210). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on August 26, 1999, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JLB
- Device class
- 1
- Regulation
- 862.1210
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Japan | 2 |
| China | 1 |
| Egypt | 1 |
| India | 1 |
| United Kingdom | 1 |
Makers of Atp And Creatine Kinase (Enzymatic), Creatine
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 |
|---|---|---|---|---|---|---|---|---|
| Abaxis, Inc. | Union City, CA, United States | Manufacturer | 1 | August 26, 1999 | 0 | 1 | 0 | api.fda.gov |
| Bialex Lab | Wichita Falls, TX, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter K. K. | Sunto-Gun Shizuoka, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter Mishima K.K. | SUNTO-GUN Shizuoka, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CTK Biotech, Inc. | Poway, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dirui Industrial Co., Ltd. | CHANGCHUN Jilin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elhoda Trade And Supplies | Badr industerial city Al Qahirah, Egypt | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lumiquick Diagnostics, Inc. | Santa Clara, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lords Mark Industries Ltd. | Daman and Diu Dadra and Nagar Haveli, India | 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 | |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 26, 1999. 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.