510(k) Report

FDA applicant

Phamatech

San Diego, CA62 decisions1996–20180 recalls

FDA records 62 decisions for Phamatech (San Diego, CA) from 1996 to 2018: 62 510(k) clearances. Most are in product codes MVO (Kit, Test, Multiple, Drugs Of Abuse, Over The…) and DJG (Enzyme Immunoassay, Opiates). Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Phamatech, Inc.”.

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

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

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

FDA decisions per year

1in 2018

2007: 22012: 12014: 12018: 1
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Phamatech’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?

  • MVOKit, Test, Multiple, Drugs Of Abuse, Over The Counter14decisions
  • DJGEnzyme Immunoassay, Opiates6decisions
  • DKZEnzyme Immunoassay, Amphetamine6decisions
  • LCXKit, Test, Pregnancy, Hcg, Over The Counter5decisions
  • LCMEnzyme Immunoassay, Phencyclidine4decisions
  • DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites4decisions

Also: LAF (4), LDJ (3), JHI (3), DIS (3), CGJ (2), JXM (2).

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 2 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.

  • K070009AT Home Drug Test Models, 9308T and 9308XPhamatech, Inc. · 20072cite it
  • K003858Modification to at Home Drug Test, Models 9150, 9068, and 9175Phamatech · 20011cites it
  • K103295Quickscreen Cocaine 150 Screening TestPhamatech, Inc. · 20121cites it

What has FDA decided for it lately?

  • K181945QuickScreen Pro Multi Drug Screening Test, Model 9395ZPhamatech, Inc. · 2018
  • K131069Quickscreen Amphetine 500 TestPhamatech, Inc. · 2014
  • K103295Quickscreen Cocaine 150 Screening TestPhamatech, Inc. · 2012
  • K070009AT Home Drug Test Models, 9308T and 9308XPhamatech, Inc. · 2007
  • K070098Quickscreen Barbiturate 300 Screening Test, Models 9019, 9018; Multi Drug Screening Test, Model 9317T; Cup…Phamatech, Inc. · 2007
  • K043599Moments Menopause Check, Model 9113Phamatech, Inc. · 2005
  • K043051Quickscreen Oxycodone Test, Models 9120, 9120T, 9120X and 9121Phamatech, Inc. · 2005
  • K043167Phamatech Quickscreen Benzodiazepines Test, Models 9025, 9026, 9027T, 9153T and 9195XPhamatech, Inc. · 2004

All 47 as Phamatech →All 15 as Phamatech, Inc. →