SAS Flualert a & B, SAS Influenza a Test
FDA 510(k) K132352 · Sa Scientific , Ltd.
510(k) numberK132352
Submission
- Device name
- SAS Flualert a & B, SAS Influenza a Test
- Applicant
- Sa Scientific , Ltd.
San Antonio, TX, US - Received
- July 29, 2013
- Decision date
- August 22, 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 |
| 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 |
| K893579 | Fitc Murine Monoclonal Anti-Influenza Type aGNX · Traditional | Whittaker Bioproducts, Inc. | 01/16/1990SE |
More from Whittaker Bioproducts, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K100227 | SAS Flualert A&B, SAS Influenza a TestPSZ · Special | 02/23/2010SE |
| K080380 | SAS Influenza a & B TestPSZ · Traditional | 07/23/2009SE |
| K061496 | SAS Legionella Test, SAS Legionella Dipstick TestMJH · Traditional | 06/28/2007SE |
| K041441 | SAS Influenza a TestPSZ · Traditional | 07/22/2004SE |
| K041439 | SAS Influenza B TestPSZ · Traditional | 07/22/2004SE |
| K030628 | SAS RSV Control KitJJX · Traditional | 03/17/2003SE |
| K022845 | SAS RSV TestGQG · Traditional | 01/29/2003SE |
| K022683 | SAS Blood/Serum/Urine/Urine HCGJHI · Traditional | 12/16/2002SE |
| K023270 | SAS StrepalertGTY · Traditional | 10/17/2002SE |
| K020438 | SAS Value HCGJHI · Abbreviated | 03/08/2002SE |
Questions and answers
When was SAS Flualert a & B, SAS Influenza a Test cleared by the FDA?
SAS Flualert a & B, SAS Influenza a Test (K132352) received a 510(k) decision of Substantially Equivalent on August 22, 2013, 24 days after the submission was received.
What is the product code of K132352?
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.