The following data is part of a premarket notification filed by Arkray, Inc. with the FDA for The Polymedco Spotchem Ex Glucose, Fructosamine And Ast Tests.
| Device ID | K041427 |
| 510k Number | K041427 |
| Device Name: | THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS |
| Classification | Glucose Oxidase, Glucose |
| 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 | CGA |
| Subsequent Product Code | CIS |
| Subsequent Product Code | LCP |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-28 |
| Decision Date | 2004-11-24 |