510(k) Report

510(k) · Cleared

Cleared

Reader

K926248510(k) TraditionalCleared May 17, 1994519-day reviewClass I21 CFR 866.2660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Alamar Biosciences Laboratory, Inc. · LRH Instrument For Auto Reader Of Overnight Microorganism Identification System

Cleared on May 17, 1994 after a 519-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
May 17, 1994
Review
519 days
Class
Class I
Product code
LRH
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K926248Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All LRH devices

LRH Instrument For Auto Reader Of Overnight Microorganism Identification System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LRH

FDA has decided no LRH device since 2007.

Median 510(k) review, days · LRH

Too few LRH 510(k)s in any year since 2007 to give a median.

Recalls per year · LRH

No recall names LRH since 2007.

Adverse event reports per year · LRH

1in 2022

2010: 12016: 62022: 1
2007high 6 (2016) · low 0 (2007)2025

MAUDE reports naming product code LRH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—01
20110—00
20120—00
20130—00
20140—00
20150—00
20160—06
20170—00
20180—00
20190—00
20200—00
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—

More from Alamar Biosciences Laboratory, Inc.

26 FDA decisions under this applicant name. See the company

  • K941425Alamar Antibiotic SusceptibilityAlamar Biosciences Laboratory, Inc. · 1994
  • K926002Alamar Bacterial Identification Test PanelAlamar Biosciences Laboratory, Inc. · 1993
  • K925951ReadarAlamar Biosciences Laboratory, Inc. · 1993
  • K930469Antimicrobial Susceptibility Test PanelAlamar Biosciences Laboratory, Inc. · 1993
  • K930055Antimicrobial Susceptibility Test PanelAlamar Biosciences Laboratory, Inc. · 1993

Recent decisions in LRH

The LRH category page

  • K962609Gram Negative Identification Plus CardBiomerieux Vitek, Inc. · 1996
  • K961042Microscan Rapid Gram-Negative Indentification Type 3 PanelDade Microscan, Inc. · 1996
  • K920225Autosceptor Identification SystemBd Becton Dickinson Vacutainer Systems Preanalytic · 1992

https://510kreport.com/device/K926248 · printed Nov 5, 2026

Cite this page

510(k) Report. “K926248: Reader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K926248

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026