510(k) Report

510(k) · Cleared

Cleared

Sas (TM) Monoclonal HCG-Slide

K930609510(k) TraditionalCleared Mar 29, 199352-day reviewClass II21 CFR 862.1155

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

Sa Scientific, Inc. · JHJ Agglutination Method, Human Chorionic Gonadotropin

Cleared on Mar 29, 1993 after a 52-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Mar 29, 1993
Review
52 days
Class
Class II
Product code
JHJ
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 K930609Source: 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 JHJ? 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 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 JHJ devices

JHJ Agglutination Method, Human Chorionic Gonadotropin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JHJ

FDA has decided no JHJ device since 2007.

Median 510(k) review, days · JHJ

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

Recalls per year · JHJ

No recall names JHJ since 2007.

Adverse event reports per year · JHJ

4in 2023

2007: 42008: 82009: 32011: 82012: 12014: 12018: 12023: 4
2007high 8 (2008) · low 0 (2010)2025

MAUDE reports naming product code JHJ, 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—04
20080—08
20090—03
20100—00
20110—08
20120—01
20130—00
20140—01
20150—00
20160—00
20170—00
20180—01
20190—00
20200—00
20210—00
20220—00
20230—04
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 JHJ

The JHJ category page

  • K972606Pregnacol Pregnancy TestImmunostics Inc., · 1997
  • K921968IN Vitro Diagnostic Reagent Set, Indir. Preg. TestTech-Co, Inc. · 1996
  • K935863Sas (TM) Direct Monoclonal HCGSa Scientific, Inc. · 1994
  • K926112Accutex Beta-HCG TestJ.S. Medical Assoc. · 1993
  • K920716Direct Pregnancy TestTech-Co, Inc. · 1992

https://510kreport.com/device/K930609 · printed Nov 4, 2026

Cite this page

510(k) Report. “K930609: Sas (TM) Monoclonal HCG-Slide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K930609

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