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 |