MJHClass II

Legionella, Spp., Elisa

21 CFR 866.3300 / Microbiology

MJH is the FDA product code for Legionella, Spp., Elisa, a class II device type, regulated under 21 CFR 866.3300. As of 2026-09-10, FDA records hold 10 510(k) clearances under this code, the most recent dated 2020-03-05, and 3 recalls.

Classification record

Product code: MJH
Device name: Legionella, Spp., Elisa
Regulation: 21 CFR 866.3300
Device class: Class II
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: 10
Ingested recalls: 3

Clearances, product code MJH

By decision year

10 clearances under product code MJH with a decision year between 1992 and 2020, 2007 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code MJH by decision year
Year	Clearances
1992	1
1994	1
1998	1
1999	1
2003	1
2007	2
2012	1
2017	1
2020	1

Applicants with the most clearances

Product code MJH

Applicants holding the most 510(k) clearances under product code MJH
Applicant	Clearances
Binax, Inc.	2
Meridian Bioscience Inc	2
Intracel Corp.	1
Abbott Diagnostics Scarborough, Inc.	1
SA Scientific, Ltd	1
SSI Diagnostica A/S	1
Trinity Biotech USA	1
Whittaker Bioproducts, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order