Osom Influenza A&B Test Model 190
FDA 510(k) K123182 · SEKISUI Diagnostics, LLC
510(k) numberK123182
Submission
- Device name
- Osom Influenza A&B Test Model 190
- Applicant
- SEKISUI Diagnostics, LLC
San Diego, CA, US - Received
- October 10, 2012
- Decision date
- November 5, 2012
- 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
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|---|---|---|---|
| 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 |
| 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 |
|---|---|---|
| K241188 | Acucy® Influenza A&B Test with the Acucy® 2 SystemPSZ · Dual Track | 04/18/2025SE |
| K192719 | Osom Ultra Plus Flu A&B Test KitPSZ · Dual Track | 04/03/2020SE |
| K182001 | Acucy Influenza A&B Test with the Acucy SystemPSZ · Dual Track | 12/17/2018SE |
| K181436 | OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II…KTN · Special | 06/22/2018SE |
| K121397 | Osom Ifob 25 Test and Patient Collection Kit Osom Ifob Control Kit Osom Ifob 50 Test KitKHE · Traditional | 12/28/2012SE |
Questions and answers
When was Osom Influenza A&B Test Model 190 cleared by the FDA?
Osom Influenza A&B Test Model 190 (K123182) received a 510(k) decision of Substantially Equivalent on November 5, 2012, 26 days after the submission was received.
What is the product code of K123182?
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.