FDA applicant

Mesa Biotech, Inc.

San Diego, CA3 decisions2018–20200 recalls

FDA records 3 decisions for Mesa Biotech, Inc. (San Diego, CA) from 2018 to 2020: 3 510(k) clearances. Most are in product codes OCC (Respiratory Virus Panel Nucleic Acid Assay…) and PGX (Groups A, C And G Beta-Hemolytic Streptococcus…). Its devices cite 2 predicates, 0 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 Mesa Biotech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2018high 2 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Mesa Biotech, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mesa Biotech, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Mesa”

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

Mesa Laboratories, Inc. 9 Mesa Medical, Inc. 7

Mesa Biotech, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Mesa”