The following data is part of a premarket notification filed by Polymedco, Inc. with the FDA for Nycocard U-albumin And U-albumin Control.
| Device ID | K053553 |
| 510k Number | K053553 |
| Device Name: | NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL |
| Classification | Albumin, Antigen, Antiserum, Control |
| Applicant | POLYMEDCO, INC. 510 FURNACE DOCK RD. Cortlandt Manor, NY 10567 |
| Contact | Helen Landricho |
| Correspondent | Helen Landricho POLYMEDCO, INC. 510 FURNACE DOCK RD. Cortlandt Manor, NY 10567 |
| Product Code | DCF |
| CFR Regulation Number | 866.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-20 |
| Decision Date | 2006-03-09 |