Panels › Microbiology › Product code PII · Class 2
Candida Species Nucleic Acid Detection System
Regulation 866.3960
0510(k)s in 12 months (3 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in PII
| Company | 510(k)s | Recalls |
|---|---|---|
| T2biosystems, Inc. | 3 | 0 |
| T2 Biosystems Inc | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 13, 2024 | K234063 | T2Candida 1.1 Panel T2biosystems, Inc. | PII |
| Dec 12, 2017 | K173536 | T2Candida 1.1 Panel T2biosystems, Inc. | PII |
| Sep 22, 2014 | DEN140019 | T2CANDIDA AND T2DX INSTRUMENT T2biosystems, Inc. | PII |
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