510(k) Report

510(k) · Cleared

Cleared

Varicella-Zoster-Comple Fix Antigen and Neg Contro

K852930510(k) TraditionalCleared Nov 12, 1985126-day reviewClass II21 CFR 866.3900

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

Microbix Biosystems, Inc. · GQX Antiserum, Cf, Varicella-Zoster

Cleared on Nov 12, 1985 after a 126-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 12, 1985
Review
126 days
Class
Class II
Product code
GQX
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K852930Source: 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 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 GQX devices

GQX Antiserum, Cf, Varicella-Zoster: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GQX

FDA has decided no GQX device since 2007.

Median 510(k) review, days · GQX

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

Recalls per year · GQX

1in 2008

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

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

Adverse event reports per year · GQX

No MAUDE report names GQX since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—10
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 Microbix Biosystems, Inc.

7 FDA decisions under this applicant name. See the company

  • K894261Toxoplasma Gondii-CF Antigen and Control AntigenMicrobix Biosystems, Inc. · 1989
  • K894262Rubella Antigen and Control AntigenMicrobix Biosystems, Inc. · 1989
  • K852929CMV-Complement Fixation Antigen and Negative ContrMicrobix Biosystems, Inc. · 1985
  • K852932Measles-Complement Fix Antigen & Negative CLTMicrobix Biosystems, Inc. · 1985
  • K852931Herpes Hominus I-Comple Fix Antigen & Negative CLTMicrobix Biosystems, Inc. · 1985

Recent decisions in GQX

The GQX category page

  • K951799Varicella-Zoster Virus Direct Immunofluorescence AssayLight Diagnostics · 1996
  • K911301VZV Igm TestGull Laboratories, Inc. · 1991
  • K883427Virgo (R) VZV-Igg ElisaElectro-Nucleonics, Inc. · 19891 recall
  • K875358VZV TestGull Laboratories, Inc. · 1988
  • K863317Enzygnost Anti-VZV Igg TestBehring Diagnostics, Inc. · 1987

https://510kreport.com/device/K852930 · printed Nov 4, 2026

Cite this page

510(k) Report. “K852930: Varicella-Zoster-Comple Fix Antigen and Neg Contro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K852930

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