510(k) Report

FDA applicant

Diagnostic Hybrids, Inc.

Athens, OH37 decisions1988–20140 recalls

FDA records 37 decisions for Diagnostic Hybrids, Inc. (Athens, OH) from 1988 to 2014: 36 510(k) clearances and 1 De Novo grant. Most are in product codes KIR (Cells, Animal And Human, Cultured) and GQN (Antigen, Cf (Including Cf Control)…). Its devices cite 31 predicates, 17 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, microbiology panel, where it files most

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

FDA decisions per year

1in 2014

2007: 42008: 32009: 82010: 12014: 1
2007high 8 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Diagnostic Hybrids, 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?

  • KIRCells, Animal And Human, Cultured13decisions
  • GQNAntigen, Cf (Including Cf Control), Herpesvirus Hominis 1,27decisions
  • GNWAntisera, Cf, Influenza Virus A, B, C5decisions
  • OMGAntisera, Fluorescent, Human Metapneumovirus3decisions
  • JZOSystem, Test, Thyroid Autoantibody2decisions
  • LJPAntiserum, Fluorescent, Chlamydia Trachomatis1decision

Also: GQW (1), PGI (1), GQL (1), GQS (1), LKT (1), LIN (1).

Whose devices does it build on?

Its devices cite 31 predicates; 17 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 19 times; 17 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.

  • K061101D3 Ultra Dfa Respiratory Virus Screening & ID KitDiagnostic Hybrids, Inc. · 20067cite it
  • K081928D3 Duet Dfa RSV/Respiratory Virus Screening KitDiagnostic Hybrids, Inc. · 20084cite it
  • K090073D3 Dfa Metapneumovirus Identification KitDiagnostic Hybrids, Inc. · 20092cite it
  • K971662Elvis HSV ID/Typing Test SystemDiagnostic Hybrids, Inc. · 19972cite it
  • K962306Fresh Cells Multi-Well & Shell Vial CulturesDiagnostic Hybrids, Inc. · 19961cites it
  • K092229Thyretain TM Tsi Reporter BioassayDiagnostic Hybrids, Inc. · 20101cites it

What has FDA decided for it lately?

  • DEN140004Quidel Molecular Direct HSV 1 +2/VZV AssayDiagnostic Hybrids, Inc. · 2014
  • K092229Thyretain TM Tsi Reporter BioassayDiagnostic Hybrids, Inc. · 2010
  • K093415D3 Fastpoint L-Dfa Parainfluenza Virus/Adenovirus Identification KitDiagnostic Hybrids, Inc. · 2009
  • K093233D3 Fastpoint L-Dfa RSV/MVP Identification KitDiagnostic Hybrids, Inc. · 2009
  • K092882D3 Fastpoint L-Dfa Influenza a/Influenza B Virus Identification KitDiagnostic Hybrids, Inc. · 2009
  • K091171D3 Ultra Duet Dfa Respiratory Virus Identification KitDiagnostic Hybrids, Inc. · 2009
  • K092300Modification to D3 Ultra Dfa Respiratory Virus Screening & ID KitDiagnostic Hybrids, Inc. · 2009
  • K091753Elvis HSV ID and D3 Typing Test SystemDiagnostic Hybrids, Inc. · 2009

All 37 as Diagnostic Hybrids, Inc. →

Other applicant names beginning “Diagnostic”

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

Diagnostic Products Corp. 324Diagnostic Systems Laboratories, Inc. 94Diagnostic Chemicals, Ltd. (Usa) 77Diagnostic Reagents, Inc. 66Diagnostic Chemicals, Ltd. 66Diagnostic Technology, Inc. 28Diagnostic Solutions, Inc. 26Diagnostic Ultrasound Corp. 16Diagnostic Systems 14Diagnostic Reagent Tech. 10Diagnostic Specialties 8Diagnostic Monitoring Software 5