The following data is part of a premarket notification filed by Arkray, Inc. with the FDA for Spotchem Ii Chemistry Basic 1 And Chemistry Basic 2 Tests.
| Device ID | K053401 |
| 510k Number | K053401 |
| Device Name: | SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS |
| Classification | Cresolphthalein Complexone, Calcium |
| 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 | CIC |
| Subsequent Product Code | CEK |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGX |
| Subsequent Product Code | CIX |
| Subsequent Product Code | JGZ |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-06 |
| Decision Date | 2006-03-24 |