The following data is part of a premarket notification filed by Polymedco, Inc. with the FDA for Polymedco Homocysteine Test For The Poly-chem And Hitachi Chemistry Systems.
| Device ID | K033706 |
| 510k Number | K033706 |
| Device Name: | POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS |
| Classification | Urinary Homocystine (nonquantitative) Test System |
| Applicant | POLYMEDCO, INC. 510 FURNACE DOCK RD. Cortlandt Manor, NY 10567 |
| Contact | Helen Landicho |
| Correspondent | Helen Landicho POLYMEDCO, INC. 510 FURNACE DOCK RD. Cortlandt Manor, NY 10567 |
| Product Code | LPS |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-26 |
| Decision Date | 2004-02-04 |