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

Instrument For Auto Reader Of Overnight Microorganism Identification System

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

LRH is the FDA product code for Instrument For Auto Reader Of Overnight Microorganism Identification System, a class I device type, regulated under 21 CFR 866.2660. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LRH
Device name
Instrument For Auto Reader Of Overnight Microorganism Identification System
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
4
Ingested recalls
0

Clearances, product code LRH

By decision year
4 clearances under product code LRH with a decision year between 1992 and 1996, 1996 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LRH by decision year
YearClearances
19921
19941
19962

Applicants with the most clearances

Product code LRH
Applicants holding the most 510(k) clearances under product code LRH
ApplicantClearances
Alamar Biosciences Laboratory, Inc.1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Biomerieux Vitek, Inc.1
Dade Microscan, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code