Virazyme Culture Confirmation Screen for Influenza and Parainfluenza Viruses
FDA 510(k) K950838 · Zymetx, Inc.
510(k) numberK950838
Submission
- Device name
- Virazyme Culture Confirmation Screen for Influenza and Parainfluenza Viruses
- Applicant
- Zymetx, Inc.
Oklahoma City, OK, US - Received
- February 24, 1995
- Decision date
- June 17, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GNT – Antigens, Ha (Including Ha Control), Influenza Virus A, B, C
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3330
- Specialty
- Microbiology
Other 510(k)s with product code GNT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K913828 | Qtest Influenza aGNT · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/23/1991SE |
| K902609 | Directigen Flu aGNT · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/10/1990SE |
| K780275 | Influenza Ha Antigen A/UssrGNT · Traditional | Flow Laboratories, Inc. | 02/28/1978SE |
| K780272 | Influenza Ha AntigenGNT · Traditional | Flow Laboratories, Inc. | 02/28/1978SE |
More from Flow Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K984596 | Virastat Fitc-Labeled Anti-Influenza a and B Monoclonal AntibodiesGNR · Traditional | 03/04/1999SE |
| K982429 | Zstatflu Test for Influenza Types a and B VirusesPSZ · Traditional | 08/25/1998SE |
| K971494 | Virazyme Influenza Id Test for Influenza Types a and B VirusesGNX · Traditional | 09/10/1997SE |
Questions and answers
When was Virazyme Culture Confirmation Screen for Influenza and Parainfluenza Viruses cleared by the FDA?
Virazyme Culture Confirmation Screen for Influenza and Parainfluenza Viruses (K950838) received a 510(k) decision of Substantially Equivalent on June 17, 1996, 479 days after the submission was received.
What is the product code of K950838?
The FDA product code is GNT – Antigens, Ha (Including Ha Control), Influenza Virus A, B, C, a Class I (low risk) device regulated under 21 CFR 866.3330.