510(k) Report

510(k) · Cleared

Cleared

Diagnostic Reagent TST-Rpla

K855236510(k) TraditionalCleared Nov 4, 1986308-day reviewClass I21 CFR 866.3700

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

Oxoid U.S.A., Inc. · GTN Antisera, Fluorescent, All Types, Staphylococcus Spp.

Cleared on Nov 4, 1986 after a 308-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 4, 1986
Review
308 days
Class
Class I
Product code
GTN
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K855236Source: 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 GTN devices

GTN Antisera, Fluorescent, All Types, Staphylococcus Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GTN

FDA has decided no GTN device since 2007.

Median 510(k) review, days · GTN

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

Recalls per year · GTN

No recall names GTN since 2007.

Adverse event reports per year · GTN

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2025

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

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—01
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Oxoid U.S.A., Inc.

93 FDA decisions under this applicant name. See the company

  • K891593Listeria Selective Enrichment MediumOxoid U.S.A., Inc. · 1989
  • K884026Escherichia Coli 0157 Latex Agglutination Test KitOxoid U.S.A., Inc. · 1989
  • K884208Listeria Selective Medium (Oxford Formulation)Oxoid U.S.A., Inc. · 1988
  • K874303Staphylase TestOxoid U.S.A., Inc. · 1987
  • K872956Sorbitol Macconkey Agar NO. 3 CM 813Oxoid U.S.A., Inc. · 1987

Recent decisions in GTN

The GTN category page

  • K855233Diagnostic Reagent Set-RplaOxoid U.S.A., Inc. · 1986
  • K851949Staphaurex ZL30Wellcome Diagnostics · 1985
  • K791453Agglutinotest-StaphylolisinVolu Sol Medical Industries · 1979

https://510kreport.com/device/K855236 · printed Nov 3, 2026

Cite this page

510(k) Report. “K855236: Diagnostic Reagent TST-Rpla.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K855236

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