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 Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays Class II Microbiology 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 Class II Microbiology
2025-08-14 K251526 FilmArray GI Control Panel M238 PMN Class II Microbiology
2024-05-30 K241289 SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control PMN Class II Microbiology
2024-03-26 K233611 SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) PMN Class II Microbiology
2023-04-13 K230868 SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control PMN Class II Microbiology
2023-02-03 K221253 SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control PMN Class II Microbiology
2022-07-22 K203680 BioFire JI Control Panel M420 PMN Class II Microbiology
2021-06-24 K202196 BioFire RP2.1/RP2.1plus Control Panel M441 PMN Class II Microbiology
2020-04-02 K200010 FilmArray BCID2 Control Panel M416 PMN Class II Microbiology
Data source: openFDA · Generated 2026-09-07 09:19 · Last ingest 2026-09-07T13:19:27.426703 · Pipeline: Chrysalis Intelligence