Data / Medical devices / Italy / BIOTECNICA INSTRUMENTS, Srl
BIOTECNICA INSTRUMENTS, Srl: FDA-registered device maker in ROME Roma, Italy, 1 510(k) clearance
BIOTECNICA INSTRUMENTS, Srl is registered with the FDA (registration 1000455123) in ROME Roma, Italy. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 20, 1995. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000455123
- Address
- Via Licenza 18, ROME Roma, Italy, 00156
- Owner or operator
- CarboLink Corporate Consulting, LLC (9038786)
- Roles
- Manufacturer
- First device listed
- June 10, 2025
- Registered through
- 2026
- Brand names listed
- Envoy 500+
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Manufacturer | accessdata.fda.gov |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Ion Specific, Potassium | CEM | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Ion Specific, Sodium | JGS | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Ion-Specific, Chloride | CGZ | 2 | Manufacturer | accessdata.fda.gov |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | 1 | 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 |
|---|---|---|---|---|---|---|
| April 20, 1995 | K945271 | ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM | JJE | Substantially Equivalent | Bio-Chem Laboratory Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- All makers of Electrode, Ion Specific, Sodium
- All makers of Electrode, Ion-Specific, Chloride
- All makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- All makers of Electrode, Ion Specific, Potassium
- All makers of Enzymatic Esterase--Oxidase, Cholesterol
Updated April 20, 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.