Remel Xpect Flu A&B
FDA 510(k) K131804 · Remel, Inc.
510(k) numberK131804
Submission
- Device name
- Remel Xpect Flu A&B
- Applicant
- Remel, Inc.
Lenexa, KS, US - Received
- June 19, 2013
- Decision date
- July 12, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K893579 | Fitc Murine Monoclonal Anti-Influenza Type aGNX · Traditional | Whittaker Bioproducts, Inc. | 01/16/1990SE |
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| K072827 | Rpmi 1640 Agar W/Mops and 2% GlucoseMJE · Traditional | 11/26/2007SE |
| K041951 | Xpect Clostridium Difficile Toxin A/BLLH · Traditional | 11/15/2004SE |
| K033479 | Prospect Clostridium Difficile Toxin A/B Microplate AssayLLH · Traditional | 02/26/2004SE |
| K031942 | Xpect Giardia Lateral Flow Assay, Model 2450020MHI · Traditional | 11/18/2003SE |
| K031965 | Xpect Cryptosporidium Lateral Flow Assay, Model 2451020MHJ · Traditional | 11/14/2003SE |
| K031834 | Xpect Giardia/Cryptosporidium Lateral Flow AssayMHI · Traditional | 11/10/2003SE |
| K031565 | Xpect Influenza A/BPSZ · Traditional | 07/17/2003SE |
| K013711 | Bacti-Swab DryLIO · Traditional | 11/26/2001SE |
Questions and answers
When was Remel Xpect Flu A&B cleared by the FDA?
Remel Xpect Flu A&B (K131804) received a 510(k) decision of Substantially Equivalent on July 12, 2013, 23 days after the submission was received.
What is the product code of K131804?
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.