510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LLHClass I

Reagents, Clostridium Difficile Toxin

21 CFR 866.2660 / Microbiology
FDA source (opens on fda.gov)

LLH is the FDA product code for Reagents, Clostridium Difficile Toxin, a class I device type, regulated under 21 CFR 866.2660. As of , FDA records hold 42 510(k) clearances under this code, the most recent dated , and 11 recalls.

Classification record

Product code
LLH
Device name
Reagents, Clostridium Difficile Toxin
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
42
Ingested recalls
11

Clearances, product code LLH

By decision year
42 clearances under product code LLH with a decision year between 1985 and 2021, 1993 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code LLH by decision year
YearClearances
19851
19861
19871
19881
19901
19913
19922
19935
19942
19961
19973
19981
19993
20001
20033
20044
20051
20071
20082
20093
20101
20211

Applicants with the most clearances

Product code LLH
Applicants holding the most 510(k) clearances under product code LLH
ApplicantClearances
Techlab, Inc.11
Meridian Diagnostics, Inc.6
Marion Laboratories, Inc.3
BD Becton Dickinson Vacutainer Systems Preanalytic2
bioMerieux, Inc.2
Advanced Clinical Diagnostics1
Alexon Biomedical, Inc.1
Alexon, Inc.1
Baxter Diagnostics, Inc.1
BD Diagnostics (Geneohm Sciences, Inc.)1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order