The following data is part of a premarket notification filed by Arkray, Inc. with the FDA for Polymedco Spotchem Ez Chemistry Analyzer.
| Device ID | K040332 |
| 510k Number | K040332 |
| Device Name: | POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER |
| Classification | Analyzer, Chemistry, Micro, For Clinical Use |
| Applicant | ARKRAY, INC. 510 FURNACE DOCK RD. Cortlandt Manor, NY 10567 |
| Contact | Helen Landicho |
| Correspondent | Helen Landicho ARKRAY, INC. 510 FURNACE DOCK RD. Cortlandt Manor, NY 10567 |
| Product Code | JJF |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CKA |
| CFR Regulation Number | 862.2170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-10 |
| Decision Date | 2004-06-16 |