510(k) Report

FDA applicant

Maine Standards Co.

Windham, ME30 decisions2001–20170 recalls

FDA records 30 decisions for Maine Standards Co. (Windham, ME) from 2001 to 2017: 30 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and JJX (Single (Specified) Analyte Controls (Assayed…). Since 2016 its 510(k)s took a median of 93 days from receipt to decision, against 96 for FDA’s reviews in the same codes and years. Its devices cite 39 predicates, 9 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Maine Standards Company, LLC”.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Maine Standards Co.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2017

2007: 12008: 12009: 32011: 22012: 12013: 12014: 12015: 12016: 12017: 3
2007high 3 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Maine Standards Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Maine Standards Co.’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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Which product codes does it file in?

  • JJYMulti-Analyte Controls, All Kinds (Assayed)19decisions
  • JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)6decisions
  • GGNPlasma, Coagulation Control4decisions
  • DKBCalibrators, Drug Mixture1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 93 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 96 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 39 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 17 times; 9 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K062501Validate Thyroid Calibration Verification / Linearity Test Set, Model 901Maine Standards Co. · 20065cite it
  • K152961VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLC · 20162cite it
  • K012120Validate Chem 4 Calibration Verification Test Set, Model 10004Maine Standards Co. · 20012cite it
  • K012117Validate Chem 1 Calibration Verification Test Set, Model 10001Maine Standards Co. · 20012cite it
  • K091225Validate GC1, GC2, GC3 and GC4 Calibration Verification/Linearity Test SetMaine Standards Co. · 20091cites it
  • K012119Validate Chem 3 Calibration Verification Test Set, Model 10003Maine Standards Co. · 20011cites it

What has FDA decided for it lately?

  • K170864VALIDATE D-Dimer Calibration Verification / Linearity Test KitMaine Standards Company, LLC · 2017
  • K163498VALIDATE Heparin Calibration Verification/Linearity Test KitMaine Standards Company, LLC · 2017
  • K162705VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitMaine Standards Company, LLC · 2017
  • K152961VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLC · 2016
  • K142964VALIDATE Anemia Calibration Verification/ Linearity Test KitMaine Standards Company, LLC · 2015
  • K133550Validate Ferritin Calibration Verification/ Linearity Test KitMaine Standards Company, LLC · 2014
  • K123127Validate Psa Calibration Verification/ Linearity Test Kit Model 406Maine Standards Co. · 2013
  • K113524Validate Vit D Calibration Verification/ Linearity Test KitMaine Standards Co. · 2012

All 23 as Maine Standards Co. →All 7 as Maine Standards Company, LLC →

Other applicant names beginning “Maine”

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

Maine Molecular Quality Controls, Inc. 15