510(k) · Cleared

Cleared

Automated Eia Microplate Reader EL310

K842085510(k) TraditionalCleared Jun 11, 198418-day reviewClass I21 CFR 862.2300

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

Bio-Tek Instruments, Inc. · JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

Cleared on Jun 11, 1984 after an 18-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided: Jun 11, 1984
Review: 18 days
Class: Class I
Product code: JJQ
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK842085 Automated Eia Microplate Reader EL310Bio-Tek Instruments, Inc. · 1984
Descendant · cites it directly · 0 of its ownK992959 Behring Coagulation System (BCS)Dade Behring, Inc. · 2000

Most influential descendants

Showing 1 of 1 · See all

K992959Behring Coagulation System (BCS)Dade Behring, Inc. · 2000 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K842085	Automated Eia Microplate Reader EL310	Bio-Tek Instruments, Inc.	1984	—
+1	K992959	Behring Coagulation System (BCS)	Dade Behring, Inc.	2000	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

FIG. 1 — Lineage of K842085, 1984–2000Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

Planning a device in JJQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K992959	Behring Coagulation System (BCS)	Dade Behring, Inc.	2000	0

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.

What does this lineage say?

Of its descendants, K992959 (Dade Behring, Inc., 2000) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JJQ devices

JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJQ

FDA has decided no JJQ device since 2007.

Median 510(k) review, days · JJQ

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

Recalls per year · JJQ

1in 2025

2007high 2 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JJQ

20in 2025

2007high 69 (2014) · low 0 (2020)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	1
2008	—	2	4
2009	—	1	10
2010	—	0	46
2011	—	1	6
2012	—	0	3
2013	—	0	63
2014	—	0	69
2015	—	0	13
2016	—	0	9
2017	—	0	10
2018	—	0	2
2019	—	0	1
2020	—	0	0
2021	—	0	3
2022	—	1	22
2023	—	0	14
2024	—	0	7
2025	—	1	20
2026	—	0	—

https://510kreport.com/device/K842085 · printed Nov 5, 2026

Cite this page

510(k) Report. “K842085: Automated Eia Microplate Reader EL310.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K842085

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026