Maine Molecular Quality Controls, Inc.: FDA clearances and approvals
Maine Molecular Quality Controls, Inc. has 14 FDA 510(k) clearances (first 2008, latest 2026), plus 1 De Novo decision, across 2 product codes in 2 review panels. Median 510(k) review time: 88 days. Since 2017 its median was 88 days, against 88 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 87 |
| 2017 | 2 | 72 |
| 2018 | 0 | — |
| 2019 | 1 | 87 |
| 2020 | 1 | 91 |
| 2021 | 1 | 323 |
| 2022 | 1 | 582 |
| 2023 | 2 | 146 |
| 2024 | 2 | 78 |
| 2025 | 1 | 87 |
| 2026 | 1 | 88 |
Review time against the same product codes
Since 2017, Maine Molecular Quality Controls, Inc.'s cleared 510(k)s took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PMN | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays | 13 | 13 |
| NZB | Quality Control Material, Genetics, Dna | 2 | 1 |
Review panels
- Microbiology (13)
- Immunology (2)
Most recent Maine Molecular Quality Controls, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260577 | FilmArray TF Control Panel M527 | PMN | 2026-05-19 | 88 |
| K251526 | FilmArray GI Control Panel M238 | PMN | 2025-08-14 | 87 |
| K241289 | SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control | PMN | 2024-05-30 | 23 |
| K233611 | SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) | PMN | 2024-03-26 | 134 |
| K230868 | SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control | PMN | 2023-04-13 | 15 |
| K221253 | SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control | PMN | 2023-02-03 | 277 |
| K203680 | BioFire JI Control Panel M420 | PMN | 2022-07-22 | 582 |
| K202196 | BioFire RP2.1/RP2.1plus Control Panel M441 | PMN | 2021-06-24 | 323 |
| K200010 | FilmArray BCID2 Control Panel M416 | PMN | 2020-04-02 | 91 |
| K190222 | FilmArray Pneumonia/Pneumoniaplus Control | PMN | 2019-05-03 | 87 |
4 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN060007 | De Novo | Quality Control Material, Genetics, Dna | 2006-10-12 |
Recalls
openFDA lists no recalls under a recalling firm named Maine Molecular Quality Controls, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Maine Molecular Quality Controls, Inc. have?
Maine Molecular Quality Controls, Inc. has 14 FDA 510(k) clearances (first 2008, latest 2026), plus 1 De Novo decision, across 2 product codes in 2 review panels.
How long does FDA take to clear Maine Molecular Quality Controls, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Maine Molecular Quality Controls, Inc.'s cleared 510(k)s is 88 days. Since 2017: 88 days, versus 88 days for all cleared 510(k)s in the same product codes.
What devices does Maine Molecular Quality Controls, Inc. make?
Its most frequent FDA product codes are PMN (Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays, 13); NZB (Quality Control Material, Genetics, Dna, 2).
Has Maine Molecular Quality Controls, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Maine Molecular Quality Controls, Inc. Related entities may recall under other names.
Next steps
- See all 14 Maine Molecular Quality Controls, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PMN, Maine Molecular Quality Controls, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.