The following data is part of a premarket notification filed by Arkray, Inc. with the FDA for Spotchem Ii Calcium, Magnesium, And Blood Urea Nitrogen Tests.
| Device ID | K050077 |
| 510k Number | K050077 |
| Device Name: | SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN 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 | JGJ |
| Subsequent Product Code | JGZ |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-12 |
| Decision Date | 2005-02-15 |