Murine Monoclonal Anti-Adenovirus Igg
FDA 510(k) K885310 · Whittaker Bioproducts, Inc.
510(k) numberK885310
Submission
- Device name
- Murine Monoclonal Anti-Adenovirus Igg
- Applicant
- Whittaker Bioproducts, Inc.
Walkersville, MD, US - Received
- December 29, 1988
- Decision date
- February 16, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GNY – Antisera, Fluorescent, Adenovirus 1-33
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3020
- Specialty
- Microbiology
Other 510(k)s with product code GNY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K922801 | Resp. Panel 1 Indirect Immunofluorescence AssayGNY · Traditional | Light Diagnostics | 01/06/1993SE |
| K770811 | Adenovirus Group-Fa Labelled PreserumGNY · Traditional | Flow Laboratories, Inc. | 05/20/1977SE |
| K770807 | Adenovirus-Group Fa Labelled (8-651 RF)GNY · Traditional | Flow Laboratories, Inc. | 05/20/1977SE |
More from Flow Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K911356 | Legionella Stat Igg/Igm Test KitMJH · Traditional | 07/30/1992SE |
| K913212 | 3M Ige Single Point Fast TestDHB · Traditional | 11/22/1991SE |
| K904652 | Lyme Stat M Test KitLSR · Traditional | 10/21/1991SE |
| K904893 | Fiax Lyme M Test KitLSR · Traditional | 10/16/1991SE |
| K911473 | Ebna Stat Test KitLLM · Traditional | 09/25/1991SE |
| K905468 | Pylori-G Fiax Test KitLYR · Traditional | 05/07/1991SE |
| K904738 | Pylori Stat Test KitLYR · Traditional | 05/07/1991SE |
| K901493 | Fitc Murine Monoclonal Anti-Influenza Type BGNX · Traditional | 06/27/1990SE |
| K893579 | Fitc Murine Monoclonal Anti-Influenza Type aGNX · Traditional | 01/16/1990SE |
| K894932 | Fiax Eb Vca-M Test KitLSE · Traditional | 10/16/1989SE |
Questions and answers
When was Murine Monoclonal Anti-Adenovirus Igg cleared by the FDA?
Murine Monoclonal Anti-Adenovirus Igg (K885310) received a 510(k) decision of Substantially Equivalent on February 16, 1989, 49 days after the submission was received.
What is the product code of K885310?
The FDA product code is GNY – Antisera, Fluorescent, Adenovirus 1-33, a Class I (low risk) device regulated under 21 CFR 866.3020.