510(k) Report

510(k) · Cleared

Cleared

Coxsackie Virus B1-B6 CF Antigens

K921618510(k) TraditionalCleared Jun 29, 199284-day reviewClass I21 CFR 866.3145

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

Virion (U.S.), Inc. · GNG Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6

Cleared on Jun 29, 1992 after an 84-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jun 29, 1992
Review
84 days
Class
Class I
Product code
GNG
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 K921618Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

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 GNG? 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
Get a 510(k) Report

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 GNG devices

GNG Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GNG

FDA has decided no GNG device since 2007.

Median 510(k) review, days · GNG

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

Recalls per year · GNG

No recall names GNG since 2007.

Adverse event reports per year · GNG

No MAUDE report names GNG 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 Virion (U.S.), Inc.

5 FDA decisions under this applicant name. See the company

  • K933251Epstein-Barr Virus Combi Test, Ebv Combi TestVirion (U.S.), Inc. · 1994
  • K905306Mumps Complement-Fixation (C.F.) AntigenVirion (U.S.), Inc. · 1991
  • K905385P.I.V. Complement-Fixation (C.F.) AntigenVirion (U.S.), Inc. · 1991
  • K864981Toxoplasma GondiiVirion (U.S.), Inc. · 1987

Recent decisions in GNG

The GNG category page

  • K850003Coxsackie B Series CF AntigensHillcrest Biologicals · 1985

https://510kreport.com/device/K921618 · printed Nov 6, 2026

Cite this page

510(k) Report. “K921618: Coxsackie Virus B1-B6 CF Antigens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K921618

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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