The following data is part of a premarket notification filed by Arkray, Inc. with the FDA for Spotchem Ii Total Bilirubin, Total Protein And Albumin Tests.
| Device ID | K051432 |
| 510k Number | K051432 |
| Device Name: | SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS |
| Classification | Diazo Colorimetry, Bilirubin |
| 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 | CIG |
| Subsequent Product Code | CEK |
| Subsequent Product Code | CIX |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-01 |
| Decision Date | 2005-06-17 |
| Summary: | summary |