FDA product code LRH: Instrument For Auto Reader Of Overnight Microorganism Identification System
LRH is the FDA product code for instrument for auto reader of overnight microorganism identification system. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under LRH, from 4 different applicants. The average 510(k) review took 195 days (median 102).
Classification
| Field | Value |
|---|---|
| Device name | Instrument For Auto Reader Of Overnight Microorganism Identification System |
| Device class | Class I |
| Regulation | 21 CFR 866.2660 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LRH clearance
Top LRH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biomerieux Vitek, Inc. | 1 | 1996-08-30 |
| Dade Microscan, Inc. | 1 | 1996-05-30 |
| Alamar Biosciences Laboratory, Inc. | 1 | 1994-05-17 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1992-05-22 |
Most recent LRH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K962609 | Biomerieux Vitek, Inc. | GRAM NEGATIVE IDENTIFICATION PLUS CARD | 1996-08-30 | 58 |
| K961042 | Dade Microscan, Inc. | MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL | 1996-05-30 | 77 |
| K926248 | Alamar Biosciences Laboratory, Inc. | READER | 1994-05-17 | 519 |
| K920225 | Bd Becton Dickinson Vacutainer Systems Preanalytic | AUTOSCEPTOR IDENTIFICATION SYSTEM | 1992-05-22 | 126 |
Recalls for LRH devices
openFDA lists no recalls for product code LRH.
Frequently asked questions
What is FDA product code LRH?
LRH is the FDA product code for instrument for auto reader of overnight microorganism identification system. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.
What device class is LRH?
Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LRH?
Across 4 cleared submissions the average was 195 days from receipt to decision (median 102).
Which companies have the most LRH clearances?
Biomerieux Vitek, Inc. (1); Dade Microscan, Inc. (1); Alamar Biosciences Laboratory, Inc. (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LRH
- Run a recall and safety report across every LRH manufacturer
- Watch product code LRH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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