Data / Medical devices / Quality Control Slides
Quality Control Slides (LJG): 13 FDA-registered makers in 1 country
13 establishments in 1 country are registered with the FDA to make Quality Control Slides (product code LJG, Class 1, 21 CFR 866.2660). 2 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 27 510(k) clearances under this code, the latest on October 27, 1994, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LJG
- Device class
- 1
- Regulation
- 866.2660
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 13 |
Makers of Quality Control Slides
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 |
|---|---|---|---|---|---|---|---|---|
| CalibreScientific US, Inc. | Vancouver, WA, United States | Manufacturer | 4 | March 30, 1988 | 0 | 0 | 0 | api.fda.gov |
| Bion Enterprises, Ltd. | Des Plaines, IL, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 1 | February 17, 1989 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Sparks, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio SB, Inc. | Santa Barbara, CA, United States | Contract manufacturer, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ELITechGroup Inc | Logan, UT, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fertility Solutions, Inc. | Warrensville Heights, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hardy Diagnostics | Orcutt, CA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microbiologics, Inc. | Saint Cloud, MN, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 2 | 0 | api.fda.gov | |
| Newcomer Supply Inc | Waunakee, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Athens, OH, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remel, Inc. | Lenexa, KS, United States | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Scytek Laboratories, Inc. | Logan, UT, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Springside Scientific LLC | Durham, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 27, 1994. 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.