FDA applicant

Maine Molecular Quality Controls, Inc.

Saco, ME15 decisions2008–20260 recalls

FDA records 15 decisions for Maine Molecular Quality Controls, Inc. (Saco, ME) from 2008 to 2026: 15 510(k) clearances. Most are in product codes PMN (Assayed External Control Material For…) and NZB (Quality Control Material, Genetics, Dna). Since 2016 its 510(k)s took a median of 88 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 12 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Maine Molecular Quality Controls, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2008high 2 (2017) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Maine Molecular Quality Controls, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Maine Molecular Quality Controls, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Maine”

FDA records each applicant name separately; these may or may not be the same firm.

Maine Standards Co. 30

Maine Molecular Quality Controls, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Maine”