The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Homocysteine Assay Buffer Based Calibrators.
| Device ID | K102638 |
| 510k Number | K102638 |
| Device Name: | DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS |
| Classification | Calibrator, Secondary |
| Applicant | DIAZYME LABORATORIES 12889 GREGG COURT Poway, CA 92064 |
| Contact | Abhijit Datta |
| Correspondent | Abhijit Datta DIAZYME LABORATORIES 12889 GREGG COURT Poway, CA 92064 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-14 |
| Decision Date | 2010-11-30 |