The following data is part of a premarket notification filed by General Atomics with the FDA for Diazyme Homocysteine Enzymatic Assay Kit.
Device ID | K042448 |
510k Number | K042448 |
Device Name: | DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT |
Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
Applicant | GENERAL ATOMICS 3550 GENERAL ATOMICS COURT San Diego, CA 92121 |
Contact | Huan Tran |
Correspondent | Huan Tran GENERAL ATOMICS 3550 GENERAL ATOMICS COURT San Diego, CA 92121 |
Product Code | JJX |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-09-09 |
Decision Date | 2004-10-29 |