Data / Medical devices / Instrumentation, High Pressure Liquid Chromatography
Instrumentation, High Pressure Liquid Chromatography (LDM): 9 FDA-registered makers in 4 countries
9 establishments in 4 countries are registered with the FDA to make Instrumentation, High Pressure Liquid Chromatography (product code LDM, Class 1, 21 CFR 862.2260). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 19 510(k) clearances under this code, the latest on July 8, 1996, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LDM
- Device class
- 1
- Regulation
- 862.2260
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| China | 3 |
| United States | 2 |
| Japan | 2 |
| Singapore | 2 |
Makers of Instrumentation, High Pressure Liquid Chromatography
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 |
|---|---|---|---|---|---|---|---|---|
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Manufacturer, Specification developer | 1 | November 10, 1994 | 0 | 0 | 0 | api.fda.gov |
| Arkray, Inc. | Kamigyo-ku Kyoto, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CEI Pte Ltd | Singapore Central Singapore, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GES Singapore Pte Ltd | Singapore North West, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infitek Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Labpeak Co.,ltd | Jinan Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scitek Global Co.,ltd | Jinan Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SEKISUI MEDICAL CO., LTD. Tokuyama Plant | Shunan-City Yamaguchi, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Waters Corporation | Milford, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 8, 1996. 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.