DDS — Prealbumin, Fitc, Antigen, Antiserum, Control Class I
FDA product code DDS covers "Prealbumin, Fitc, Antigen, Antiserum, Control", a Class I medical device regulated under 21 CFR 866.5060. Submissions are reviewed by the Immunology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DDS
- Device Class
- Class I
- Regulation Number
- 866.5060
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K972812 | hemagen diagnostics | RAICHEM PREALBUMIN SPIA | August 28, 1997 |
| K964781 | beckman instruments | IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT | May 9, 1997 |
| K934966 | incstar | SPQ PAL CONTROL LEVEL II | January 11, 1994 |
| K854811 | beckman instruments | ICS PAB PREALBUMIN REAGENT TEST KIT | January 24, 1986 |