The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Homocysteine Enzymatic Assay Kit For Cobas Integra And Homocysteine Calibrator.
| Device ID | K061296 |
| 510k Number | K061296 |
| Device Name: | DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR |
| Classification | Urinary Homocystine (nonquantitative) Test System |
| Applicant | DIAZYME LABORATORIES 3550 GENERAL ATOMICS CT. San Diego, CA 92121 |
| Contact | Roland Strickland |
| Correspondent | Roland Strickland DIAZYME LABORATORIES 3550 GENERAL ATOMICS CT. San Diego, CA 92121 |
| Product Code | LPS |
| CFR Regulation Number | 862.1377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-09 |
| Decision Date | 2006-06-13 |