510(k) Report

510(k) · Cleared

Cleared

Immuno-Tec II OT Agarose Plate Kit

K761270510(k) TraditionalCleared Dec 30, 197614-day reviewClass I21 CFR 866.4600

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

Behring Diagnostics, Inc. · JZP Plates, Ouchterlony Agar

Cleared on Dec 30, 1976 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 30, 1976
Review
14 days
Class
Class I
Product code
JZP
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K761270Source: 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 JZP? 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 JZP devices

JZP Plates, Ouchterlony Agar: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JZP

FDA has decided no JZP device since 2007.

Median 510(k) review, days · JZP

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

Recalls per year · JZP

No recall names JZP since 2007.

Adverse event reports per year · JZP

No MAUDE report names JZP 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 Behring Diagnostics, Inc.

146 FDA decisions under this applicant name. See the company

  • K973832Opus HLH ControlsBehring Diagnostics, Inc. · 1997
  • K972929N Antiserum to Human AlbuminBehring Diagnostics, Inc. · 1997
  • K972840N Antiserum to Human TransferrinBehring Diagnostics, Inc. · 1997
  • K973202Modification of Opus Ferritin Test SystemBehring Diagnostics, Inc. · 1997
  • K972316Opus D-DimerBehring Diagnostics, Inc. · 1997

https://510kreport.com/device/K761270 · printed Nov 6, 2026

Cite this page

510(k) Report. “K761270: Immuno-Tec II OT Agarose Plate Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K761270

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