Influenza a Antigen Test
FDA 510(k) K942172 · Neogenex
510(k) numberK942172
Submission
- Device name
- Influenza a Antigen Test
- Applicant
- Neogenex
Everett, WA, US - Received
- May 5, 1994
- Decision date
- July 6, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GNW – Antisera, Cf, 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 GNW
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|---|---|---|---|
| K092882 | D3 Fastpoint L-Dfa Influenza A/Influenza B Virus Identification KitGNW · Traditional | Diagnostic Hybrids, Inc. | 10/21/2009SE |
| K092300 | Modification to D3 Ultra Dfa Respiratory Virus Screening & Id KitGNW · Special | Diagnostic Hybrids, Inc. | 08/28/2009SE |
| K081746 | D3 Duet Dfa Influenza A/Respiratory Virus Screening KitGNW · Traditional | Diagnostic Hybrids, Inc. | 12/23/2008SE |
| K061101 | D3 Ultra Dfa Respiratory Virus Screening & Id KitGNW · Traditional | Diagnostic Hybrids, Inc. | 11/20/2006SE |
| K022713 | Dfa Respiratory Virus Screening & Id KitGNW · Traditional | Diagnostic Hybrids, Inc. | 12/18/2002SE |
| K003204 | Bartels Viral Respiratory Screening and Identification KitGNW · Special | Intracel Corp. | 11/07/2000SE |
| K974302 | Light Diagnostics Simulfluor Flu A/Flu BGNW · Traditional | Light Diagnostics | 04/08/1998SE |
| K973954 | Imagen Respiratory ScreenGNW · Traditional | Dako Diagnostics , Ltd. | 12/22/1997SE |
| K962037 | Imagen Respiratory ScreenGNW · Traditional | Dako Diagnostics , Ltd. | 12/26/1996SE |
| K942174 | Influenza B Anitgen TestGNW · Traditional | Neogenex | 06/30/1994SE |
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| K943891 | RD Culture CellKIR · Traditional | 11/28/1994SE |
| K943890 | WI38 Cell CultureKIR · Traditional | 11/28/1994SE |
| K943889 | Vero Cell CultureKIR · Traditional | 11/28/1994SE |
| K943888 | MDCK Cell CultureKIR · Traditional | 11/28/1994SE |
| K943887 | Human Newborn Foreskin Cell CultureKIR · Traditional | 11/28/1994SE |
| K943886 | BGM Cell CultureKIR · Traditional | 11/28/1994SE |
| K943885 | Primary Rabbit Kidney Cell CultureKIR · Traditional | 11/28/1994SE |
| K943884 | Primary Monkey Kidney Cell CultureKIR · Traditional | 11/28/1994SE |
Questions and answers
When was Influenza a Antigen Test cleared by the FDA?
Influenza a Antigen Test (K942172) received a 510(k) decision of Substantially Equivalent on July 6, 1994, 62 days after the submission was received.
What is the product code of K942172?
The FDA product code is GNW – Antisera, Cf, Influenza Virus A, B, C, a Class I (low risk) device regulated under 21 CFR 866.3330.