510(k) Report

510(k) · Cleared

Cleared

CD-Chex CD4 Low

K931825510(k) TraditionalCleared Jun 6, 1994426-day reviewClass II21 CFR 864.8625

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

Streck Laboratories, Inc. · GGL Control, White-Cell

Cleared on Jun 6, 1994 after a 426-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 6, 1994
Review
426 days
Class
Class II
Product code
GGL
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K931825Source: 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 GGL? 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 GGL devices

GGL Control, White-Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GGL

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GGL

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

Recalls per year · GGL

No recall names GGL since 2007.

Adverse event reports per year · GGL

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2025

MAUDE reports naming product code GGL, 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—00
20080—00
20091—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—01
20240—00
20250—00
20260—0—

More from Streck Laboratories, Inc.

70 FDA decisions under this applicant name. See the company

  • K042587Retic-Chex for Cell-DynStreck Laboratories, Inc. · 2004
  • K040107Cyto-Chex BCTStreck Laboratories, Inc. · 2004
  • K040025A1C-CellularStreck Laboratories, Inc. · 2004
  • K023656Sickle-Chex Solubility KitStreck Laboratories, Inc. · 2002
  • K021922Modification to Para 5XStreck Laboratories, Inc. · 2002

Recent decisions in GGL

The GGL category page

  • K083926CD4 CountStreck · 2009
  • K051633CD-Chex Plus BCStreck · 2005
  • K993126CD-Chex CD 34Streck Laboratories, Inc. · 1999
  • K960894CD-Chex + RBCStreck Laboratories, Inc. · 1996
  • K920997CD-ChexStreck Laboratories, Inc. · 1992

https://510kreport.com/device/K931825 · printed Nov 6, 2026

Cite this page

510(k) Report. “K931825: CD-Chex CD4 Low.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931825

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