510(k) Report

510(k) · Cleared

Cleared

Sas Shigella Boydii Type 15 Antiserum

K961548510(k) TraditionalCleared May 20, 199628-day reviewClass II21 CFR 866.3660

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

Sa Scientific, Inc. · GNB Antisera, All Types, Shigella Spp.

Cleared on May 20, 1996 after a 28-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
May 20, 1996
Review
28 days
Class
Class II
Product code
GNB
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 K961548Source: 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 GNB devices

GNB Antisera, All Types, Shigella Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GNB

FDA has decided no GNB device since 2007.

Median 510(k) review, days · GNB

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

Recalls per year · GNB

1in 2017

2007: 22017: 1
2007high 2 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GNB

1in 2021

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

MAUDE reports naming product code GNB, 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—20
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—10
20180—00
20190—00
20200—00
20210—01
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 GNB

The GNB category page

  • K961537Sas Shigella Sonnei Form II AntiserumSa Scientific, Inc. · 1996
  • K961554Sas Shigella Boydii Type 10 AntiserumSa Scientific, Inc. · 1996
  • K961559Sas Shigella Dysenteriae Type 9 AntiserumSa Scientific, Inc. · 1996
  • K961553Sas Shigella Dysenteriae Type 1 AntiserumSa Scientific, Inc. · 1996
  • K961542Sas Shigella Flexneri Type 4 AntiserumSa Scientific, Inc. · 1996

https://510kreport.com/device/K961548 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961548: Sas Shigella Boydii Type 15 Antiserum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961548

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