510(k) Report

510(k) · Cleared

Cleared

Dryside Neisseria

K954784510(k) TraditionalCleared Jan 30, 1996105-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

Difco Laboratories, Inc. · LTS Test Reagents, Neisseria Gonorrhoeae Biochemical

Cleared on Jan 30, 1996 after a 105-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 30, 1996
Review
105 days
Class
Class I
Product code
LTS
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K954784Source: 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 LTS? 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 LTS devices

LTS Test Reagents, Neisseria Gonorrhoeae Biochemical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LTS

FDA has decided no LTS device since 2007.

Median 510(k) review, days · LTS

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

Recalls per year · LTS

No recall names LTS since 2007.

Adverse event reports per year · LTS

No MAUDE report names LTS 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 Difco Laboratories, Inc.

121 FDA decisions under this applicant name. See the company

  • K971120Dispens-O-Disc (TM) LevofloxacinDifco Laboratories, Inc. · 1997
  • K971211Dispens-O-Disc SparfloxacinDifco Laboratories, Inc. · 1997
  • K963508Dispens-O-Disc MeropenemDifco Laboratories, Inc. · 1996
  • K961148Cefepime Dispans-O-Disc (Cefeplime - 30MCG)Difco Laboratories, Inc. · 1996
  • K954783Dryslide CartarrhalisDifco Laboratories, Inc. · 1996

Recent decisions in LTS

The LTS category page

https://510kreport.com/device/K954784 · printed Nov 5, 2026

Cite this page

510(k) Report. “K954784: Dryside Neisseria.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954784

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