Fitc Murine Monoclonal Anti-Influenza Type B
FDA 510(k) K901493 · Whittaker Bioproducts, Inc.
510(k) numberK901493
Submission
- Device name
- Fitc Murine Monoclonal Anti-Influenza Type B
- Applicant
- Whittaker Bioproducts, Inc.
Walkersville, MD, US - Received
- March 29, 1990
- Decision date
- June 27, 1990
- 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 |
| K893579 | Fitc Murine Monoclonal Anti-Influenza Type aGNX · Traditional | Whittaker Bioproducts, Inc. | 01/16/1990SE |
More from Whittaker Bioproducts, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K911356 | Legionella Stat Igg/Igm Test KitMJH · Traditional | 07/30/1992SE |
| K913212 | 3M Ige Single Point Fast TestDHB · Traditional | 11/22/1991SE |
| K904652 | Lyme Stat M Test KitLSR · Traditional | 10/21/1991SE |
| K904893 | Fiax Lyme M Test KitLSR · Traditional | 10/16/1991SE |
| K911473 | Ebna Stat Test KitLLM · Traditional | 09/25/1991SE |
| K905468 | Pylori-G Fiax Test KitLYR · Traditional | 05/07/1991SE |
| K904738 | Pylori Stat Test KitLYR · Traditional | 05/07/1991SE |
| K893579 | Fitc Murine Monoclonal Anti-Influenza Type aGNX · Traditional | 01/16/1990SE |
| K894932 | Fiax Eb Vca-M Test KitLSE · Traditional | 10/16/1989SE |
| K894235 | Eb Vca Stat M Test KitLSE · Traditional | 08/30/1989SE |
Questions and answers
When was Fitc Murine Monoclonal Anti-Influenza Type B cleared by the FDA?
Fitc Murine Monoclonal Anti-Influenza Type B (K901493) received a 510(k) decision of Substantially Equivalent on June 27, 1990, 90 days after the submission was received.
What is the product code of K901493?
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.