The following data is part of a premarket notification filed by Arkray, Inc. with the FDA for Spotchem Ii Inoganic Phosphorus, Cpk And Uric Acid Tests.
| Device ID | K051648 |
| 510k Number | K051648 |
| Device Name: | SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| 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 | CGS |
| Subsequent Product Code | CEO |
| Subsequent Product Code | KNK |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-21 |
| Decision Date | 2006-01-31 |