510(k) Report

FDA applicant

Intl. Mycoplasma/Mdc Assoc.

Manchester, MA1 decision1990–19900 recalls

FDA records 1 decision for Intl. Mycoplasma/Mdc Assoc. (Manchester, MA) in 1990: 1 510(k) clearance. All are in product code GSA (Antisera, All Mycoplasma Spp.). 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 Intl. Mycoplasma/Mdc Assoc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Intl. Mycoplasma/Mdc Assoc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Intl. Mycoplasma/Mdc Assoc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Intl. Mycoplasma/Mdc Assoc.’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