510(k) · Cleared
ClearedVirazyme Culture Confirmation Screen for Influenza and Parainfluenza Viruses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zymetx, Inc. · GNT Antigens, Ha (Including Ha Control), Influenza Virus A, B, C
Cleared on Jun 17, 1996 after a 479-day review. The FDA summary names no predicate by number.
- Decided
- Jun 17, 1996
- Review
- 479 days
- Class
- Class I
- Product code
- GNT
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GNT? 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
What was it cleared against?
The FDA summary names no predicate by number.
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 GNT devicesGNT Antigens, Ha (Including Ha Control), Influenza Virus A, B, C: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GNT
FDA has decided no GNT device since 2007.
Median 510(k) review, days · GNT
Too few GNT 510(k)s in any year since 2007 to give a median.
Recalls per year · GNT
No recall names GNT since 2007.
Adverse event reports per year · GNT
No MAUDE report names GNT since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ViraZyme® Culture Confirmation Screen for Influenza and Parainfluenza is intended for use as a screening test for respiratory viral cultures infected with influenza type A and B and parainfluenza types 1, 2, 3, and 4. This test will screen culture fluids for the presence of these viruses, but it is not indented for the definitive typing of these viruses.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K950838 · printed Nov 5, 2026
Cite this page
510(k) Report. “K950838: Virazyme Culture Confirmation Screen for Influenza and Parainfluenza Viruses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K950838
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026