Data / Medical devices / Mixture, Control, White-Cell And Red-Cell Indices
Mixture, Control, White-Cell And Red-Cell Indices (GLQ): 4 FDA-registered makers in 2 countries
4 establishments in 2 countries are registered with the FDA to make Mixture, Control, White-Cell And Red-Cell Indices (product code GLQ, Class 2, 21 CFR 864.8625). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on December 22, 2011, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GLQ
- Device class
- 2
- Regulation
- 864.8625
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Japan | 1 |
Makers of Mixture, Control, White-Cell And Red-Cell Indices
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 |
|---|---|---|---|---|---|---|---|---|
| Streck LLC | La Vista, NE, United States | Contract manufacturer, Manufacturer | 5 | August 23, 2010 | 0 | 0 | 0 | api.fda.gov |
| Abbott Laboratories | Irving, TX, United States | Specification developer | 1 | April 18, 2000 | 0 | 0 | 0 | api.fda.gov |
| Sysmex Corporation Techno Park | KOBE Hyogo, Japan | Specification developer | 1 | January 14, 2000 | 0 | 0 | 0 | api.fda.gov |
| STS Corporation | Duluth, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 22, 2011. 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.