510(k) Report

FDA applicant

Rapid Diagnostics, Inc.

Burlingame, CA4 decisions1998–20040 recalls

FDA records 4 decisions for Rapid Diagnostics, Inc. (Burlingame, CA) from 1998 to 2004: 4 510(k) clearances. Most are in product codes DKZ (Enzyme Immunoassay, Amphetamine) and JHI (Visual, Pregnancy Hcg, Prescription Use). 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 Rapid Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rapid Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Rapid Diagnostics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DKZEnzyme Immunoassay, Amphetamine2decisions
  • JHIVisual, Pregnancy Hcg, Prescription Use1decision
  • DJGEnzyme Immunoassay, Opiates1decision

Who builds on its devices?

Later devices cite its devices 3 times; 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.

  • K033566Micromedic Drugs of Abuse Panel Test (9), Catalog Number 07RD-7062Rapid Diagnostics, Inc. · 20042cite it
  • K003809Rapid Drugs of Abuse Single and Multiple Test PanelsRapid Diagnostics, Inc. · 20011cites it

What has FDA decided for it lately?

  • K033566Micromedic Drugs of Abuse Panel Test (9), Catalog Number 07RD-7062Rapid Diagnostics, Inc. · 2004
  • K020716Rapid Opiates Test Strip II, Rapid Opiates Test Card II and Doa Multiple Drug Test Cards (UP to Six Tests)Rapid Diagnostics, Inc. · 2002
  • K003809Rapid Drugs of Abuse Single and Multiple Test PanelsRapid Diagnostics, Inc. · 2001
  • K981770Rapidhcg Pregnancy TestRapid Diagnostics, Inc. · 1998

All 4 as Rapid Diagnostics, Inc. →

Other applicant names beginning “Rapid”

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

Rapid Medical, Ltd. 12Rapid City Regional Hospital, Inc. 10Rapid Biomedical GmbH 7Rapid Diagnostic Laboratories, Inc. 6Rapid Pathogen Screening, Inc. 3Rapid Aid Corp. 3Rapid Injection Systems Corp. 2Rapid Reboot Recovery Products, LLC 2Rapid Mfg. Co. 1Rapid-Aid Ltd./Ltee 1Rapid Response Solutions, LLC 1Rapid Nexus Nanotech Wound Solutions, Inc. 1