510(k) Report

510(k) · Cleared

Cleared

Elvi 655 Flame Photometer

K843375510(k) TraditionalCleared May 20, 1985265-day reviewClass I21 CFR 862.2540

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

Logos Scientific, Inc. · JJO Flame Emission Photometer For Clinical Use

Cleared on May 20, 1985 after a 265-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 20, 1985
Review
265 days
Class
Class I
Product code
JJO
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K843375Source: 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.

Planning a device in JJO? 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
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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 JJO devices

JJO Flame Emission Photometer For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJO

FDA has decided no JJO device since 2007.

Median 510(k) review, days · JJO

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

Recalls per year · JJO

No recall names JJO since 2007.

Adverse event reports per year · JJO

No MAUDE report names JJO 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 Logos Scientific, Inc.

9 FDA decisions under this applicant name. See the company

  • K902614Elvi 828 Digiclot MultiscanLogos Scientific, Inc. · 1990
  • K844710Eurochima Serum Protein Electrophoresis MethodLogos Scientific, Inc. · 1985
  • K843296Elvi 675 DigitronLogos Scientific, Inc. · 1984
  • K842313Elvi 146 SeroscanLogos Scientific, Inc. · 1984
  • K842056Elvi 165 Proteo SeroskopLogos Scientific, Inc. · 1984

Recent decisions in JJO

The JJO category page

  • K873603Finnigan Mat Incos 50Finnigan Corp. · 1987
  • K862148Olympus AU 5000 Flame Photometer ModuleOlympus Corp. · 1986
  • K841847Lithium ReagentReagent Laboratory, Inc. · 1984
  • K834226Flame PhotometersDr. Bruno Lange GmbH · 1984
  • K841421Daily Wash Solution 5Reagent Laboratory, Inc. · 1984

https://510kreport.com/device/K843375 · printed Nov 5, 2026

Cite this page

510(k) Report. “K843375: Elvi 655 Flame Photometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K843375

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