The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Creatinine Liquid Reagents Assay.
| Device ID | K062105 |
| 510k Number | K062105 |
| Device Name: | DIAZYME CREATININE LIQUID REAGENTS ASSAY |
| Classification | Enzymatic Method, Creatinine |
| Applicant | DIAZYME LABORATORIES 3550 GENERAL ATOMICS CT. San Diego, CA 92121 |
| Contact | Abhijit Datta |
| Correspondent | Abhijit Datta DIAZYME LABORATORIES 3550 GENERAL ATOMICS CT. San Diego, CA 92121 |
| Product Code | JFY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-24 |
| Decision Date | 2007-04-23 |
| Summary: | summary |