Maine Standards Company, LLC: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Maine Standards Company, LLC” (first 2011, latest 2017), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 97 days. Since 2017 the median was 93 days, against 93 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 78 |
| 2015 | 1 | 198 |
| 2016 | 1 | 240 |
| 2017 | 3 | 93 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Maine Standards Company, LLC took a median 93 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 93 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GGN | Plasma, Coagulation Control | 4 | 4 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 | 2 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
Review panels
- Hematology (4)
- Clinical Chemistry (3)
Most recent Maine Standards Company, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170864 | VALIDATE D-Dimer Calibration Verification / Linearity Test Kit | GGN | 2017-06-21 | 90 |
| K163498 | VALIDATE Heparin Calibration Verification/Linearity Test Kit | GGN | 2017-03-16 | 93 |
| K162705 | VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit | GGN | 2017-01-05 | 99 |
| K152961 | VALIDATE D-Dimer Calibration Verification/Linearity Test Kit | GGN | 2016-06-03 | 240 |
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test Kit | JJY | 2015-04-30 | 198 |
| K133550 | VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT | JJX | 2014-02-05 | 78 |
| K110880 | VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT | JJY | 2011-07-05 | 97 |
Recalls
openFDA lists no recalls under a recalling firm named Maine Standards Company, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Maine Standards Co. (23 510(k)s)
- Maine Molecular Quality Controls, Inc. (14 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Maine Standards Company, LLC?
FDA lists 7 510(k) clearances under the applicant name “Maine Standards Company, LLC” (first 2011, latest 2017), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Maine Standards Company, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Maine Standards Company, LLC is 97 days. Since 2017: 93 days, versus 93 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Maine Standards Company, LLC?
The most frequent FDA product codes under this applicant name are GGN (Plasma, Coagulation Control, 4); JJY (Multi-Analyte Controls, All Kinds (Assayed), 2); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 1).
Next steps
- See all 7 Maine Standards Company, LLC clearances with predicates and recalls
- Run predicate analysis for product code GGN, Maine Standards Company, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.