Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Maine Molecular Quality Controls, Inc. with 16 510(k) clearances. The most recent is a 510(k) clearance dated Oct 30, 2026: eplex RP3 Control M530; eplex RP3 Negative.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 30, 2026 | eplex RP3 Control M530; eplex RP3 NegativeK263232 · PMN | 510(k) clearances |
| Oct 21, 2026 | SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative ControlK262573 · PMN | 510(k) clearances |
| May 19, 2026 | FilmArray TF Control Panel M527K260577 · PMN | 510(k) clearances |
| Aug 14, 2025 | FilmArray GI Control Panel M238K251526 · PMN | 510(k) clearances |
| May 30, 2024 | SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative ControlK241289 · PMN | 510(k) clearances |
| Mar 26, 2024 | SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)K233611 · PMN | 510(k) clearances |
| Apr 13, 2023 | SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative ControlK230868 · PMN | 510(k) clearances |
| Feb 3, 2023 | SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative ControlK221253 · PMN | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
