510(k) Report

510(k) · Cleared

Cleared

Sas (TM) QC Antigens for Salmonella Antisera

K945839510(k) TraditionalCleared Mar 7, 199597-day reviewClass II21 CFR 866.3550

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

Sa Scientific, Inc. · GRL Antigens, All Groups, Salmonella Spp.

Cleared on Mar 7, 1995 after a 97-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Mar 7, 1995
Review
97 days
Class
Class II
Product code
GRL
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 K945839Source: 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 GRL devices

GRL Antigens, All Groups, Salmonella Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GRL

FDA has decided no GRL device since 2007.

Median 510(k) review, days · GRL

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

Recalls per year · GRL

No recall names GRL since 2007.

Adverse event reports per year · GRL

No MAUDE report names GRL 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 Sa Scientific, Inc.

199 FDA decisions under this applicant name. See the company

  • K100227Sas Flualert a&B, Sas Influenza a TestSa Scientific, Inc. · 2010
  • K080380Sas Influenza a & B TestSa Scientific, Inc. · 2009
  • K041439Sas Influenza B TestSa Scientific, Inc. · 2004
  • K041441Sas Influenza a TestSa Scientific, Inc. · 2004
  • K030628Sas RSV Control KitSa Scientific, Inc. · 2003

Recent decisions in GRL

The GRL category page

  • K820996Salmonella & Shigella Grouping SeraFisher Scientific Co., LLC · 1982

https://510kreport.com/device/K945839 · printed Nov 6, 2026

Cite this page

510(k) Report. “K945839: Sas (TM) QC Antigens for Salmonella Antisera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945839

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