510(k) Report

510(k) · Cleared

Cleared

Neisseria Meningitidis GR. a

K840510510(k) TraditionalCleared Mar 23, 198446-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

Scientific Device Laboratory, Inc. · LSC Neisseria Controls

Cleared on Mar 23, 1984 after a 46-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 23, 1984
Review
46 days
Class
Class I
Product code
LSC
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K840510Source: 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 LSC devices

LSC Neisseria Controls: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LSC

FDA has decided no LSC device since 2007.

Median 510(k) review, days · LSC

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

Recalls per year · LSC

No recall names LSC since 2007.

Adverse event reports per year · LSC

No MAUDE report names LSC 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 Scientific Device Laboratory, Inc.

28 FDA decisions under this applicant name. See the company

  • K935316Parasafe (R) FixativeScientific Device Laboratory, Inc. · 1994
  • K924893Microsporidium Control SlideScientific Device Laboratory, Inc. · 1993
  • K911059Turbidometric StandardScientific Device Laboratory, Inc. · 1991
  • K895848Pressure Steam SterilizersScientific Device Laboratory, Inc. · 1989
  • K890670Cryptosporidium Control SlideScientific Device Laboratory, Inc. · 1989

Recent decisions in LSC

The LSC category page

  • K840506Haemophilus Influenzae Type BScientific Device Laboratory, Inc. · 1984
  • K840514Neisseria Meningitidis ControlScientific Device Laboratory, Inc. · 1984
  • K840507Neisseria Meningitidis GR. YScientific Device Laboratory, Inc. · 1984
  • K840509Neisseria Meningitidis GR. BScientific Device Laboratory, Inc. · 1984
  • K840505SDL Neisseria Menningitidis GR. XScientific Device Laboratory, Inc. · 1984

https://510kreport.com/device/K840510 · printed Nov 5, 2026

Cite this page

510(k) Report. “K840510: Neisseria Meningitidis GR. a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K840510

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