In Fluenza B Virus
FDA 510(k) K843660 · Institute Virion , Ltd.
510(k) numberK843660
Submission
- Device name
- In Fluenza B Virus
- Applicant
- Institute Virion , Ltd.
Oakland, CA, US - Received
- September 17, 1984
- Decision date
- September 26, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GNX – Antigens, Cf (Including Cf 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 GNX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K133411 | Alere Binaxnow Influenza a & B CardGNX · Special | Alere Scarborough, Inc D/B/A Binax, Inc. | 12/05/2013SE |
| K132352 | SAS Flualert a & B, SAS Influenza a TestGNX · Special | Sa Scientific , Ltd. | 08/22/2013SE |
| K131804 | Remel Xpect Flu A&BGNX · Special | Remel, Inc. | 07/12/2013SE |
| K131606 | Sofia Influenza A+B FiaGNX · Special | Quidel Corp. | 07/05/2013SE |
| K131599 | Quick Vue InfluenzaGNX · Special | Quidel Corporation | 07/05/2013SE |
| K131619 | Quickvue Influenza A+BGNX · Special | Quidel Corp. | 06/28/2013SE |
| K123182 | Osom Influenza A&B Test Model 190GNX · Special | SEKISUI Diagnostics, LLC | 11/05/2012SE |
| K971494 | Virazyme Influenza Id Test for Influenza Types a and B VirusesGNX · Traditional | Zymetx, Inc. | 09/10/1997SE |
| K924006 | Bartel Prima System Influenza a Enzyme ImmunoassayGNX · Traditional | Baxter Healthcare Corp | 12/29/1992SE |
| K901493 | Fitc Murine Monoclonal Anti-Influenza Type BGNX · Traditional | Whittaker Bioproducts, Inc. | 06/27/1990SE |
More from Whittaker Bioproducts, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K862814 | Complement-Fixation Test for Campylobacter JejuniLQP · Traditional | 09/30/1986SE |
| K843676 | Varicella/Zoster VirusGQW · Traditional | 09/26/1985SE |
| K843673 | Respiratory Syncytial VirusGQG · Traditional | 09/26/1985SE |
| K843667 | Parainfluenza 3GQS · Traditional | 09/26/1985SE |
| K843665 | Parainfluenza 1GQS · Traditional | 09/26/1985SE |
| K843662 | Measles Virus RubeolaGRJ · Traditional | 09/26/1985SE |
| K843659 | Influenza A2 VirusGNX · Traditional | 09/26/1985SE |
| K843658 | H. Simplex VirusGQN · Traditional | 09/26/1985SE |
| K843657 | CytomegalovirusGQH · Traditional | 09/26/1985SE |
| K843649 | AdenovirusGOD · Traditional | 09/26/1985SE |
Questions and answers
When was In Fluenza B Virus cleared by the FDA?
In Fluenza B Virus (K843660) received a 510(k) decision of Substantially Equivalent on September 26, 1985, 374 days after the submission was received.
What is the product code of K843660?
The FDA product code is GNX – Antigens, Cf (Including Cf Control), Influenza Virus A, B, C, a Class I (low risk) device regulated under 21 CFR 866.3330.