510(k) Report

FDA applicant

Prepared Media Laboratory, Inc.

Portland, OR3 decisions1979–19960 recalls

FDA records 3 decisions for Prepared Media Laboratory, Inc. (Portland, OR) from 1979 to 1996: 3 510(k) clearances. Most are in product codes JSO (Culture Media, Antimicrobial Susceptibility…) and JSN (Culture Media, Propagating Transport). 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 Prepared Media Laboratory, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Prepared Media Laboratory, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Prepared Media Laboratory, 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?

  • JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar1decision
  • JSNCulture Media, Propagating Transport1decision
  • JTYCulture Media, For Isolation Of Pathogenic Neisseria1decision

What has FDA decided for it lately?

  • K962744Haemophilus Test Medium Agar (HTM)Prepared Media Laboratory, Inc. · 1996
  • K962745Enteric Pathogen Transport (Ept) (E1020,E1000)Prepared Media Laboratory, Inc. · 1996
  • K782117Martin-Lewis MediumPrepared Media Laboratory, Inc. · 1979

All 3 as Prepared Media Laboratory, Inc. →