GNM — Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6 Class I
FDA product code GNM covers "Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6", a Class I medical device regulated under 21 CFR 866.3145. Submissions are reviewed by the Microbiology panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GNM
- Device Class
- Class I
- Regulation Number
- 866.3145
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K936254 | light diagnostics | COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY | September 8, 1995 |
| K940471 | chemicon intl | COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIES | September 8, 1995 |
| K936145 | chemicon intl | COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY | September 8, 1995 |
| K936253 | light diagnostics | COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY | September 8, 1995 |
| K936251 | light diagnostics | COXSACKIEVIRUS B3 MONOCLONAL ANTIBODY | September 8, 1995 |
| K936252 | light diagnostics | COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY | September 8, 1995 |
| K936073 | chemicon intl | ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS | September 8, 1995 |
| K936089 | chemicon intl | COXSACKIE A24 VIRUS MONOCLONAL ANTIBODY | September 8, 1995 |
| K940472 | chemicon intl | COXSACKIEVIRUS B5 MONOCLONAL ANTIBODY | September 8, 1995 |