DAN — Fibrinopeptide A, Antigen, Antiserum, Control Class II
FDA Device Classification
Classification Details
- Product Code
- DAN
- Device Class
- Class II
- Regulation Number
- 866.5350
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K884496 | altana | RIA/MAT FPA TEST KIT | November 16, 1988 |
| K854384 | american bioproducts | ASSERACHROM FPA KIT | February 4, 1986 |
| K821151 | mallinckrodt critical care | RIA-QUANT FPA TEST KIT | July 22, 1982 |