510(k) Report

FDA product code · Microbiology

Antigen, Blastomyces Dermatitidis, Other

LSHClass II21 CFR 866.3060510(k) exempt0 decisions0 recalls

FDA lists LSH as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 866.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, microbiology panel

Twenty years of LSH at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · LSH

FDA has decided no LSH device since 2007.

Median 510(k) review, days · LSH

Too few LSH 510(k)s in any year since 2007 to give a median.

Recalls per year · LSH

No recall names LSH since 2007.

Adverse event reports per year · LSH

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2025

MAUDE reports naming product code LSH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—01
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — LSH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LSH? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 866.3060.

MJL Eia, Blastomyces DermatitidisLSI Antiserum, Blastomyces Dermatitidis, OtherMDC Dna-Probe - Blastomyces DermatitidisKFH Antiserum, Positive Control, Blastomyces…JWW Antigen, Cf, B. Dermatitidis