510(k) Report

FDA applicant

Innovative Diagnostic Systems, Inc.

Atlanta, GA11 decisions1981–19962 recalls

FDA records 11 decisions for Innovative Diagnostic Systems, Inc. (Atlanta, GA) from 1981 to 1996: 11 510(k) clearances. Most are in product codes JTO (Discs, Strips And Reagents, Microorganism…) and JSP (Kit, Anaerobic Identification). 2 recalls are 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 Innovative Diagnostic Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Innovative Diagnostic Systems, Inc. since 2007.

Recalls per year

1in 2013

2009: 12013: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Innovative Diagnostic Systems, 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?

  • JTODiscs, Strips And Reagents, Microorganism Differentiation3decisions
  • JSPKit, Anaerobic Identification2decisions
  • JSSKit, Identification, Enterobacteriaceae2decisions
  • JSWKit, Identification, Glucose Nonfermenter1decision
  • JSXKit, Identification, Neisseria Gonorrhoeae1decision
  • JXBKit, Identification, Yeast1decision

Also: JWX (1).

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.

  • K881501Modified Ids Rapid NH SystemInnovative Diagnostic Systems, Inc. · 19881cites it

What has FDA decided for it lately?

  • K962966Ids Rapid CB Plus SystemInnovative Diagnostic Systems, Inc. · 1996
  • K943621Rapid Yeast Plus SystemInnovative Diagnostic Systems, Inc. · 19952 recalls
  • K900517Rapid NF SystemInnovative Diagnostic Systems, Inc. · 1990
  • K882960Ids Rapid Ana SystemInnovative Diagnostic Systems, Inc. · 1988
  • K881501Modified Ids Rapid NH SystemInnovative Diagnostic Systems, Inc. · 1988
  • K852871Ids Rapid SS/U SystemInnovative Diagnostic Systems, Inc. · 1985
  • K852110Ids Rapid E Plus SystemInnovative Diagnostic Systems, Inc. · 1985
  • K833654Ids Rapid STR SystemInnovative Diagnostic Systems, Inc. · 1984

All 11 as Innovative Diagnostic Systems, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K943621remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle…Apr 4, 2013Class II
  • K943621ERIC (Electronic RapID Compendium) Version 1.0.77, Catalog Number R8323600, used in…Oct 28, 2009