GQT — Antisera, Cf, Parainfluenza Virus 1-4 Class I
FDA product code GQT covers "Antisera, Cf, Parainfluenza Virus 1-4", a Class I medical device regulated under 21 CFR 866.3400. 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
- GQT
- Device Class
- Class I
- Regulation Number
- 866.3400
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K872695 | sita | PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGEN | September 18, 1987 |
| K872696 | sita | PARAINFLUENZA-3-CF ANTIGEN AND CONTROL ANTIGEN | September 18, 1987 |
| K872697 | sita | PARAINFLUENZA-I-CF ANTIGEN AND CONTROL ANTIGEN | September 18, 1987 |
| K780008 | northeast biomedical labs | GOAT ANTI-INFLUENZA ANTISERA | January 20, 1978 |