Chrysalis Intelligence · Sponsors · Maine Molecular Quality Controls, Inc.

Maine Molecular Quality Controls, Inc.

Saco, ME, US · 9 510(k) clearances

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Total clearances
9
2020-04-02 → 2026-05-19
Last 12 months
1
Product codes
1
Most recent
2026-05-19
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
PMN — — — 9 2026-05-19
Filings

All 510(k) clearances (9)

Date K-number Device Code Class Specialty
2026-05-19 K260577 FilmArray TF Control Panel M527 PMN — —
2025-08-14 K251526 FilmArray GI Control Panel M238 PMN — —
2024-05-30 K241289 SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control PMN — —
2024-03-26 K233611 SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) PMN — —
2023-04-13 K230868 SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control PMN — —
2023-02-03 K221253 SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control PMN — —
2022-07-22 K203680 BioFire JI Control Panel M420 PMN — —
2021-06-24 K202196 BioFire RP2.1/RP2.1plus Control Panel M441 PMN — —
2020-04-02 K200010 FilmArray BCID2 Control Panel M416 PMN — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence