Company ยท US
Sdi Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2016. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 12, 2016 | K150515 | IQSense Flow Sensor Mouthpiece Sdi Diagnostics, Inc. | BZG |
| Jul 16, 2010 | K092813 | ASTRASONIC SPIROMETER, MODEL 29-8000 Sdi Diagnostics, Inc. | BZG |
| Jan 31, 2007 | K061571 | ASTRA 300 Sdi Diagnostics, Inc. | BZG |
| Jan 26, 2007 | K062913 | ASTRAGUARD PULMONARY FUNCTION FILTER Sdi Diagnostics, Inc. | BZG |
| Jan 30, 2004 | K033939 | FLOSENSE II, MODEL 29-8040 Sdi Diagnostics, Inc. | BZG |
| Dec 9, 2003 | K031643 | SPIROTEL, MODEL 29-1020 Sdi Diagnostics, Inc. | BZG |
| Feb 11, 2002 | K013812 | SPIROLAB II, MODEL 29 Sdi Diagnostics, Inc. | BZG |
| Oct 12, 2001 | K011470 | SDI SB OFFICE, MODEL 29- Sdi Diagnostics, Inc. | BZG |
| Jan 7, 2000 | K990962 | FLOSENSE, MODEL 29-8010 Sdi Diagnostics, Inc. | JAX |
| Oct 21, 1993 | K934509 | PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER Sdi Diagnostics, Inc. | CAH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||