The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Carbon Dioxide Enzymatic Assay Kit, Model Kz122a.
| Device ID | K060619 |
| 510k Number | K060619 |
| Device Name: | DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A |
| Classification | Enzymatic, Carbon-dioxide |
| 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 | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-08 |
| Decision Date | 2006-07-21 |
| Summary: | summary |