510(k) Report

510(k) · Cleared

Cleared

Kallestad RSV Microplate Eia

K924289510(k) TraditionalCleared Feb 12, 1993175-day reviewClass I21 CFR 866.3480

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

Bio-Rad Laboratories, Inc. · MCE Respiratory Syncytial Virus - Elisa

Cleared on Feb 12, 1993 after a 175-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 12, 1993
Review
175 days
Class
Class I
Product code
MCE
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K924289Source: 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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What was it cleared against?

FDA has not posted a summary or statement for it, 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 MCE devices

MCE Respiratory Syncytial Virus - Elisa: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MCE

FDA has decided no MCE device since 2007.

Median 510(k) review, days · MCE

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

Recalls per year · MCE

No recall names MCE since 2007.

Adverse event reports per year · MCE

No MAUDE report names MCE since 2007.

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

More from Bio-Rad Laboratories, Inc.

103 FDA decisions under this applicant name. See the company

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  • K161687D-10 Hemoglobin A1c ProgramBio-Rad Laboratories, Inc. · 2016
  • K151321D-100 HbA1c, D-100 HbA1c Calibrator PackBio-Rad Laboratories, Inc. · 2015
  • K142448VARIANT II TURBO HbA1c Kit - 2.0Bio-Rad Laboratories, Inc. · 2015

Recent decisions in MCE

The MCE category page

  • K061008Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199Quidel Corp. · 2006

https://510kreport.com/device/K924289 · printed Nov 4, 2026

Cite this page

510(k) Report. “K924289: Kallestad RSV Microplate Eia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K924289

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