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 |