Imagen Influenza Virus a and B Testmi
FDA 510(k) K872958 · Boots-Celltech Diagnostics, Inc.
510(k) numberK872958
Submission
- Device name
- Imagen Influenza Virus a and B Testmi
- Applicant
- Boots-Celltech Diagnostics, Inc.
Berkshire, England, GB - Received
- July 29, 1987
- Decision date
- February 24, 1988
- 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 |
|---|---|---|
| K871877 | Ideia Herpes Simplex Virus TestLGC · Traditional | 11/17/1989SE |
| K880799 | Modified Ideia Chlamydia TestLJC · Traditional | 12/08/1988SE |
| K880758 | Sucrosep Specific Immunoradiometric AssayCEP · Traditional | 04/18/1988SE |
| K874875 | Chemelia Free THYROXINE(FT4)/ENZYME Immuno. (Eia)CEC · Traditional | 03/24/1988SE |
| K872843 | Oveia (TM) Dual AnalyteJLP · Traditional | 02/02/1988SE |
| K873625 | Chemelia Enzyme Immunoassay for (TSH)JLM · Traditional | 10/20/1987SE |
| K872056 | Modified (Directions for Use) for Ideia(Tm) TestLJC · Traditional | 06/15/1987SE |
| K870602 | Imagen Herpes Simplex Virus (HSV) Typing TestGQN · Traditional | 05/08/1987SE |
| K864998 | Ideia(Tm) Chlamydia Specimen Collection KitJSM · Traditional | 04/20/1987SE |
| K864539 | Modified Imagen(Tm) Chlamydia TestLJP · Traditional | 03/12/1987SE |
Questions and answers
When was Imagen Influenza Virus a and B Testmi cleared by the FDA?
Imagen Influenza Virus a and B Testmi (K872958) received a 510(k) decision of Substantially Equivalent on February 24, 1988, 210 days after the submission was received.
What is the product code of K872958?
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.