510(k) Report

FDA applicant

Rapid Diagnostic Laboratories, Inc.

Port Washington, NY6 decisions1985–19900 recalls

FDA records 6 decisions for Rapid Diagnostic Laboratories, Inc. (Port Washington, NY) from 1985 to 1990: 6 510(k) clearances. Most are in product codes DIF (Drug Mixture Control Materials) and KRJ (Filter, Prebypass, Cardiopulmonary Bypass). 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 Diagnostic Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rapid Diagnostic Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • DIFDrug Mixture Control Materials3decisions
  • KRJFilter, Prebypass, Cardiopulmonary Bypass1decision
  • DKBCalibrators, Drug Mixture1decision
  • LASDrug Specific Control Materials1decision

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.

  • K850139Cobe Cop Filter Cardiopulmonary Prebypass FilterRapid Diagnostic Laboratories, Inc. · 19851cites it

What has FDA decided for it lately?

  • K903909Blind Controls for Drugs of Abuse TestingRapid Diagnostic Laboratories, Inc. · 1990
  • K890030New Low Level Drug Mixture ControlRapid Diagnostic Laboratories, Inc. · 1989
  • K875216High Performance CalibratorsRapid Diagnostic Laboratories, Inc. · 1988
  • K871694Hyperformance Controls (HP-Controls)Rapid Diagnostic Laboratories, Inc. · 1987
  • K863117High Performance Cannabinoid ControlsRapid Diagnostic Laboratories, Inc. · 1986
  • K850139Cobe Cop Filter Cardiopulmonary Prebypass FilterRapid Diagnostic Laboratories, Inc. · 1985

All 6 as Rapid Diagnostic Laboratories, 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 Diagnostics, Inc. 4Rapid 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