GNY — Antisera, Fluorescent, Adenovirus 1-33 Class I
FDA product code GNY covers "Antisera, Fluorescent, Adenovirus 1-33", a Class I medical device regulated under 21 CFR 866.3020. Submissions are reviewed by the Microbiology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GNY
- Device Class
- Class I
- Regulation Number
- 866.3020
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K922801 | light diagnostics | RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY | January 6, 1993 |
| K885310 | whittaker bioproducts | MURINE MONOCLONAL ANTI-ADENOVIRUS IGG | February 16, 1989 |
| K770811 | flow laboratories | ADENOVIRUS GROUP-FA LABELLED PRESERUM | May 20, 1977 |
| K770807 | flow laboratories | ADENOVIRUS-GROUP FA LABELLED (8-651 RF) | May 20, 1977 |