Sdi Diagnostics, Inc.
South Easton, MA, US
SDI DIAGNOSTICS, INC. appears in FDA device records in South Easton, MA. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Sdi Diagnostics, Inc. between 1993 and 2016. The busiest year on record is 2007, with 2. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2007 | 2 |
| 2010 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K150515 | IQSense Flow Sensor Mouthpiece | BZG | Substantially Equivalent | |
| K092813 | ASTRASONIC SPIROMETER, MODEL 29-8000 | BZG | Substantially Equivalent | |
| K061571 | ASTRA 300 | BZG | Substantially Equivalent | |
| K062913 | ASTRAGUARD PULMONARY FUNCTION FILTER | BZG | Substantially Equivalent | |
| K033939 | FLOSENSE II, MODEL 29-8040 | BZG | Substantially Equivalent | |
| K031643 | SPIROTEL, MODEL 29-1020 | BZG | Substantially Equivalent | |
| K013812 | SPIROLAB II, MODEL 29 | BZG | Substantially Equivalent | |
| K011470 | SDI SB OFFICE, MODEL 29- | BZG | Substantially Equivalent | |
| K990962 | FLOSENSE, MODEL 29-8010 | JAX | Substantially Equivalent | |
| K934509 | PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER | CAH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1220253 | 1220253 | SDI DIAGNOSTICS, INC. | 10 Hampden Dr, South Easton, MA 02375 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain