Maine Standards Co.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Maine Standards Co.” (first 2001, latest 2013), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 50 days. 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 | 1 | 59 |
| 2013 | 1 | 253 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 17 | 17 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 5 | 5 |
| DKB | Calibrators, Drug Mixture | 1 | 1 |
Review panels
Most recent Maine Standards Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123127 | VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 | JJX | 2013-06-14 | 253 |
| K113524 | VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT | JJX | 2012-01-27 | 59 |
| K103271 | MSC LIPID CONTROL | JJY | 2011-01-25 | 81 |
| K091225 | VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET | JJY | 2009-06-25 | 59 |
| K090475 | VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402 | JJY | 2009-04-16 | 51 |
| K083891 | VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901 | JJY | 2009-03-23 | 84 |
| K082067 | MSC LIPID CONTROL | JJY | 2008-08-22 | 31 |
| K072246 | VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601 | JJY | 2007-09-14 | 32 |
| K062501 | VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901 | JJX | 2006-09-29 | 35 |
| K053247 | VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET | JJY | 2006-01-13 | 53 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Maine Standards Co..
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 Molecular Quality Controls, Inc. (14 510(k)s)
- Maine Standards Company, LLC (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Maine Standards Co.?
FDA lists 23 510(k) clearances under the applicant name “Maine Standards Co.” (first 2001, latest 2013), 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 Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Maine Standards Co. is 50 days.
Which FDA product codes appear under Maine Standards Co.?
The most frequent FDA product codes under this applicant name are JJY (Multi-Analyte Controls, All Kinds (Assayed), 17); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 5); DKB (Calibrators, Drug Mixture, 1).
Next steps
- See all 23 Maine Standards Co. clearances with predicates and recalls
- Run predicate analysis for product code JJY, Maine Standards Co.'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.