Prealbumin, Fitc, Antigen, Antiserum, Control
FDA product code DDS · Class I (low risk) · 21 CFR 866.5060 · Immunology
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972812 | Raichem Prealbumin SpiaDDS · Traditional | Hemagen Diagnostics, Inc. | 08/28/1997SE |
| K964781 | Immage Immunochemistry System Prealbumin (Pab) ReagentDDS · Traditional | Beckman Instruments, Inc. | 05/09/1997SE |
| K934966 | SPQ Pal Control Level IIDDS · Traditional | Incstar Corp. | 01/11/1994SE |
| K854811 | Ics Pab Prealbumin Reagent Test KitDDS · Traditional | Beckman Instruments, Inc. | 01/24/1986SE |