510(k) Report

FDA applicant

Biophor Diagnostics, Inc.

Redwood City, CA7 decisions2013–20150 recalls

FDA records 7 decisions for Biophor Diagnostics, Inc. (Redwood City, CA) from 2013 to 2015: 7 510(k) clearances. Most are in product codes LAF (Gas Chromatography, Methamphetamine) and DJG (Enzyme Immunoassay, Opiates). Its devices cite 8 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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 Biophor Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2015

2013: 22014: 22015: 3
2013high 3 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Biophor Diagnostics, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biophor Diagnostics, Inc.’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?

  • LAFGas Chromatography, Methamphetamine2decisions
  • DJGEnzyme Immunoassay, Opiates1decision
  • DKZEnzyme Immunoassay, Amphetamine1decision
  • DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites1decision
  • LDJEnzyme Immunoassay, Cannabinoids1decision
  • LCMEnzyme Immunoassay, Phencyclidine1decision

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K122703Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and Rapidease Oral Fluid CollectorBiophor Diagnostics, Inc. · 20131cites it

What has FDA decided for it lately?

  • K142293Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret…Biophor Diagnostics, Inc. · 2015
  • K142129Rapidfret Oral Fluid Assay for Cocaine, Rapidfret Oral Fluid Cocaine Calibrator Set, Rapidfret Oral Fluid…Biophor Diagnostics, Inc. · 2015
  • K141748Rapidfret Oral Fluid Assay for Amphetamine, Rapidfret Oral Fluid Amphetamine Calibrator Set, Rapidfret Oral…Biophor Diagnostics, Inc. · 2015
  • K133047Rapidfret Oral Fluid Assay for Mdma, Rapidfret Oral Fluid Calibrators, Rapidfret Oral Fluid Controls…Biophor Diagnostics, Inc. · 2014
  • K133642Rapidfret Oral Fluid Assay for Opiates; Rapidfret Oral Fluid Calibrators, Controls, Collector; Rapidfret…Biophor Diagnostics, Inc. · 2014
  • K132096Rapidfret Oral Fluid Assay for THC, THC Calibrator Set, THC Control Set, CollectorBiophor Diagnostics, Inc. · 2013
  • K122703Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and Rapidease Oral Fluid CollectorBiophor Diagnostics, Inc. · 2013

All 7 as Biophor Diagnostics, Inc. →