510(k) Report

510(k) · Cleared

Cleared

Cysticercosis Serological Reagents

K900780510(k) TraditionalCleared Oct 4, 1990226-day reviewClass I21 CFR 866.3200

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

Lmd Laboratories · MDJ Reagents, Cysticercosis

Cleared on Oct 4, 1990 after a 226-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 4, 1990
Review
226 days
Class
Class I
Product code
MDJ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K900780Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

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 MDJ? 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?

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 MDJ devices

MDJ Reagents, Cysticercosis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MDJ

FDA has decided no MDJ device since 2007.

Median 510(k) review, days · MDJ

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

Recalls per year · MDJ

No recall names MDJ since 2007.

Adverse event reports per year · MDJ

No MAUDE report names MDJ 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 Lmd Laboratories

12 FDA decisions under this applicant name. See the company

  • K955345LMD Cryptosporidium Antigen DetectionLmd Laboratories · 1996
  • K942705E. Coli 0157 Elisa Stool AssayLmd Laboratories · 1995
  • K944871LMD Giardia Antigen Detection AssayLmd Laboratories · 1995
  • K905598Cryptosporidium Antigen DetectionLmd Laboratories · 1991
  • K904613Trichinella Serology Microtiter ElisaLmd Laboratories · 1991

https://510kreport.com/device/K900780 · printed Nov 6, 2026

Cite this page

510(k) Report. “K900780: Cysticercosis Serological Reagents.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900780

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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