510(k) Report

FDA applicant

American Micro Scan

West Sacramento, CA25 decisions1979–19874 recalls

FDA records 25 decisions for American Micro Scan (West Sacramento, CA) from 1979 to 1987: 24 510(k) clearances and 1 original PMA approval. Most are in product codes JWY (Manual Antimicrobial Susceptibility Test Systems) and LJP (Antiserum, Fluorescent, Chlamydia Trachomatis). 4 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 American Micro Scan’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Micro Scan since 2007.

Recalls per year

1in 2014

2011: 32014: 1
2007high 3 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — American Micro Scan 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?

  • JWYManual Antimicrobial Susceptibility Test Systems3decisions
  • LJPAntiserum, Fluorescent, Chlamydia Trachomatis2decisions
  • JTODiscs, Strips And Reagents, Microorganism Differentiation2decisions
  • JTAMonitor, Microbial Growth1decision
  • GRPAntisera, All Types, H. Influenza1decision
  • LQLGram Positive Identification Panel1decision

Also: JJQ (1), JSM (1), JWX (1), GWC (1), LDW (1), JTS (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.

  • K864389Chlamydiae Flourescent Monoclonal Antibody TestAmerican Micro Scan · 19861cites it

What has FDA decided for it lately?

  • K870029Immunoscan (TM) Direct Streptococcus PneumoniaeAmerican Micro Scan · 1987
  • K864662Chlamydiae Fluor. AB Test for Detection in SmearsAmerican Micro Scan · 1987
  • K863776Microdilution Mic PanelsAmerican Micro Scan · 1987
  • K864674Microdilution Identification PanelsAmerican Micro Scan · 1987
  • K864389Chlamydiae Flourescent Monoclonal Antibody TestAmerican Micro Scan · 1986
  • K863038Gram Positive Fluorescent Identification PanelAmerican Micro Scan · 1986
  • K862642Gram Negative Fluorescent Identification PanelAmerican Micro Scan · 1986
  • K862332Anaerobe Rapid Chromogenic ID PanelAmerican Micro Scan · 1986

All 25 as American Micro Scan →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K862140MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan…May 14, 2014Class II
  • K862140MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type…Jun 16, 2011
  • K862140MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type…Jun 16, 2011
  • K862140MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Urine Combo 55; Catalog…Jun 16, 2011