510(k) Report

510(k) · Cleared

Cleared

Human Igg Subclasses Nephelometric Bna Kit

K944876510(k) TraditionalCleared Dec 15, 199473-day reviewClass I21 CFR 866.5530

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

Research Diagnostics, Inc. · DAS Igg (Fc Fragment Specific), Antigen, Antiserum, Control

Cleared on Dec 15, 1994 after a 73-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Dec 15, 1994
Review
73 days
Class
Class I
Product code
DAS
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K944876Source: 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 lists a 510(k) statement for it but has not posted the file, 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 DAS devices

DAS Igg (Fc Fragment Specific), Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DAS

FDA has decided no DAS device since 2007.

Median 510(k) review, days · DAS

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

Recalls per year · DAS

No recall names DAS since 2007.

Adverse event reports per year · DAS

No MAUDE report names DAS 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 Research Diagnostics, Inc.

3 FDA decisions under this applicant name. See the company

  • K943098Human Igg Subclasses Elisa Combi KitResearch Diagnostics, Inc. · 1994
  • K943205Human Igg Subclasses Rid Combi Kit (Modification)Research Diagnostics, Inc. · 1994

Recent decisions in DAS

The DAS category page

  • K982023Pelicalss Human Igg Subclass Nephlometric Array KitInova Diagnostics, Inc. · 1998
  • K943205Human Igg Subclasses Rid Combi Kit (Modification)Research Diagnostics, Inc. · 1994
  • K943098Human Igg Subclasses Elisa Combi KitResearch Diagnostics, Inc. · 1994
  • K895600Human (Igg) Subclass (Eia) KitThe Binding Site, Ltd. · 1989
  • K790708Antiserum to Human IG G FC FragmentsKent Laboratories, Inc. · 1979

https://510kreport.com/device/K944876 · printed Nov 6, 2026

Cite this page

510(k) Report. “K944876: Human Igg Subclasses Nephelometric Bna Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944876

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