LRGClass II

Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

21 CFR 866.1640 / Microbiology

LRG is the FDA product code for Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems, a class II device type, regulated under 21 CFR 866.1640. As of 2026-09-10, FDA records hold 45 510(k) clearances under this code, the most recent dated 2019-11-06, and 13 recalls.

Classification record

Product code: LRG
Device name: Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Regulation: 21 CFR 866.1640
Device class: Class II
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 45
Ingested recalls: 13

Clearances, product code LRG

By decision year

45 clearances under product code LRG with a decision year between 1987 and 2019, 2006 the highest year at 18.

Show the numbers

510(k) clearances under FDA product code LRG by decision year
Year	Clearances
1987	1
1988	1
1990	2
1991	1
1992	1
1993	5
1994	1
1998	1
2004	2
2005	3
2006	18
2007	1
2008	1
2010	1
2011	4
2019	2

Applicants with the most clearances

Product code LRG

Applicants holding the most 510(k) clearances under product code LRG
Applicant	Clearances
Siemens Healthcare Diagnostics Inc.	27
BD Becton Dickinson Vacutainer Systems Preanalytic	3
Trek Diagnostic Systems, Ltd.	3
Alamar Biosciences Laboratory, Inc.	2
Alamar Biosciences, Inc.	2
Baxter Healthcare Corporation	2
Thermo Fisher Scientific Oy	2
Analytical Products, Inc.	1
Baxter Diagnostics, Inc.	1
Dade Microscan, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code