Company
Foundation Medicine, Inc.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
10recalls (5 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| PQP | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System | 10 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2026 | Foundation Medicine, Inc. Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx. Open, Classified |
PQP | None listed |
| Apr 23, 2026 | Foundation Medicine, Inc. Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990 Open, Classified |
PQP | None listed |
| Apr 22, 2026 | Foundation Medicine, Inc. Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) Open, Classified |
PQP | None listed |
| Nov 21, 2025 | Foundation Medicine, Inc. FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0 Open, Classified |
PQP | None listed |
| Nov 21, 2025 | Foundation Medicine, Inc. FoundationOne CDx (F1CDx), RAL-0003 version 31.0 Open, Classified |
PQP | None listed |
| May 30, 2025 | Foundation Medicine, Inc. FoundationOne Companion Diagnostic (F1CDx) Open, Classified |
PQP | None listed |
| May 30, 2025 | Foundation Medicine, Inc. FoundationOne Companion Diagnostic (F1CDx) Open, Classified |
PQP | None listed |
| May 12, 2025 | Foundation Medicine, Inc. FoundationOne Companion Diagnostic (F1CDx) Open, Classified |
PQP | None listed |
| Aug 8, 2019 | Foundation Medicine, Inc. FoundationOne CDx test report Terminated |
PQP | None listed |
| Dec 20, 2018 | Foundation Medicine, Inc. FoundationOne CDx Test Results Terminated |
PQP | None listed |