# Maine Standards Co.

- Location (FDA's records): Windham, ME
- FDA decisions: 30 (2001–2017): 30 510(k) clearances
- Names in FDA's records: Maine Standards Co. (23); Maine Standards Company, LLC (7)
- Product codes: JJY (19), JJX (6), GGN (4), DKB (1)
- 510(k) review time since 2016: median 93 days, against 96 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 39 (9 its own); citations of its devices by later devices: 17 (9 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Casco Standards: 20 (https://510kreport.com/company/casco-standards)
- Bio-Rad: 3 (https://510kreport.com/company/bio-rad)
- Cliniqa Corporation: 2 (https://510kreport.com/company/cliniqa)
- Aalto Scientific, Ltd.: 1 (https://510kreport.com/company/aalto-scientific)
- Sigma Diagnostics, Inc.: 1 (https://510kreport.com/company/sigma-diagnostics)
- Casco-Nerl Diagnostics Corporation (Maine): 1 (https://510kreport.com/company/casco-nerl-diagnostics-maine)
- Instrumentation Laboratory CO: 1 (https://510kreport.com/company/instrumentation-laboratory)
- Bio-Rad Laboratories, Inc.: 1 (https://510kreport.com/company/bio-rad-laboratories)

## Firms that cite its devices most
- Siemens Healthcare Diagnostics, Inc.: 4 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Polymer Technology Systems, Inc.: 2 (https://510kreport.com/company/polymer-technology-systems)
- Radiometer America, Inc.: 1 (https://510kreport.com/company/radiometer-america)
- Aalto Scientific, Ltd.: 1 (https://510kreport.com/company/aalto-scientific)

## Its most-cited devices
- K062501: Validate Thyroid Calibration Verification / Linearity Test Set, Model 901 (2006), cited by 5
- K152961: VALIDATE D-Dimer Calibration Verification/Linearity Test Kit (2016), cited by 2
- K012120: Validate Chem 4 Calibration Verification Test Set, Model 10004 (2001), cited by 2
- K012117: Validate Chem 1 Calibration Verification Test Set, Model 10001 (2001), cited by 2
- K091225: Validate GC1, GC2, GC3 and GC4 Calibration Verification/Linearity Test Set (2009), cited by 1
- K012119: Validate Chem 3 Calibration Verification Test Set, Model 10003 (2001), cited by 1

## Recent decisions
- K170864: VALIDATE D-Dimer Calibration Verification / Linearity Test Kit (Jun 21, 2017)
- K163498: VALIDATE Heparin Calibration Verification/Linearity Test Kit (Mar 16, 2017)
- K162705: VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit (Jan 5, 2017)
- K152961: VALIDATE D-Dimer Calibration Verification/Linearity Test Kit (Jun 3, 2016)
- K142964: VALIDATE Anemia Calibration Verification/ Linearity Test Kit (Apr 30, 2015)
- K133550: Validate Ferritin Calibration Verification/ Linearity Test Kit (Feb 5, 2014)
- K123127: Validate Psa Calibration Verification/ Linearity Test Kit Model 406 (Jun 14, 2013)
- K113524: Validate Vit D Calibration Verification/ Linearity Test Kit (Jan 27, 2012)

Source page: https://510kreport.com/company/maine-standards