Data / Medical devices / United States / KSL Biomedical, Inc.
KSL Biomedical, Inc.: FDA-registered device maker in Buffalo, NY, United States, 3 510(k) clearances
KSL Biomedical, Inc. is registered with the FDA (registration 3017505309) in Buffalo, NY, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 1, 1992. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3017505309
- Address
- 55 Amherst Villa Road, Buffalo, NY, United States, 14225
- Owner or operator
- KSL Diagnostics Inc. (10075006)
- Roles
- Manufacturer
- First device listed
- August 30, 2022
- Registered through
- 2026
- Brand names listed
- C-Reactive Protein (CRP) Latex Test, RPR Carbon Antigen, Rheumatoid Factor (RF) Latex Test
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antigens, Nontreponemal, All | GMQ | 2 | Manufacturer | accessdata.fda.gov |
| C-Reactive Protein, Antigen, Antiserum, And Control | DCK | 2 | Manufacturer | accessdata.fda.gov |
| System, Test, Rheumatoid Factor | DHR | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 1, 1992 | K923768 | PULSE CRP TEST | DCK | Substantially Equivalent | Pulse Scientific, Inc. | accessdata.fda.gov |
| October 5, 1992 | K923771 | PULSE RF TEST | DHR | Substantially Equivalent | Pulse Scientific, Inc. | accessdata.fda.gov |
| March 10, 1987 | K864731 | OCEAN SCIENTIFIC VDRL TEST | GMQ | Substantially Equivalent | Ocean Scientific, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Test, Rheumatoid Factor
- All makers of C-Reactive Protein, Antigen, Antiserum, And Control
- All makers of Antigens, Nontreponemal, All
Updated December 1, 1992. 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.