Data / Medical devices / United States / Statsure Diagnostic Systems
Statsure Diagnostic Systems: FDA-registered device maker in Brooklyn, NY, United States, 1 510(k) clearance
Statsure Diagnostic Systems is registered with the FDA (registration 3008264082) in Brooklyn, NY, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 21, 1995. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008264082
- Address
- 1337 E 9TH ST, Brooklyn, NY, United States, 11230
- Owner or operator
- StatSure Diagnostic Systems (10053144)
- Roles
- Specification developer
- First device listed
- November 3, 2016
- Registered through
- 2026
- Brand names listed
- Quantisal, Saliva Sampler
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device | PJD | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| August 21, 1995 | K942435 | SALIVA SAMPLER | PJD | Substantially Equivalent | Saliva Diagnostic Systems, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 21, 1995. 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.