FDA product code · Microbiology

Reagents, Clostridium Difficile Toxin

Name: FDA decisions, review times, recalls and adverse event reports for product code LLH
Creator: 510(k) Report

LLHClass I21 CFR 866.2660510(k) exempt42 decisions since 19858 recalls

FDA lists LLH 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. 42 FDA decisions since 1985. 510(k) reviews decided 2021–2025 took a median of 569 days (half between 569 and 569). 8 recalls name this code, 0 of them Class I. The most-cited predicate is K081920, named by 5 later devices.

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 LLH 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 · LLH

1in 2021

2007high 3 (2009) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLH

84in 2009

2007high 84 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLH

1in 2021

2007high 2 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLH

1in 2025

2007high 1 (2010) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	0
2008	2	—	0	0
2009	3	84	0	0
2010	1	—	1	1
2011	0	—	0	0
2012	0	—	2	0
2013	0	—	2	0
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	1	—	1	1
2022	0	—	0	1
2023	0	—	0	1
2024	0	—	0	1
2025	0	—	0	1
2026	0	—	0	—

FIG. 1 — LLH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LLH? 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 866.2660.

NZS Fish (Fluorescent In Situ Hybridization) Kit…JSR Kit, Identification, Dermatophyte OMN C. Difficile Nucleic Acid Amplification Test…JXC Kit, Screening, Yeast JWZ Kit, Screening, Trichomonas JSZ Kit, Identification, Pseudomonas JSP Kit, Anaerobic Identification JST Kit, Fastidious Organisms JSY Kit, Identification, Mycobacteria LQL Gram Positive Identification Panel LQM Gram Negative Identification Panel MJM Dna Probe, Gardnerella Vaginalis

Reagents, Clostridium Difficile Toxin

Which predicates do LLH devices cite most?

Which LLH devices have the deepest lineage?

What has FDA decided in LLH lately?

What has been recalled in LLH lately?

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