The following data is part of a premarket notification filed by General Atomics with the FDA for Diazyme Apolipoprotein A-1 Assay.
Device ID | K072977 |
510k Number | K072977 |
Device Name: | DIAZYME APOLIPOPROTEIN A-1 ASSAY |
Classification | Apolipoproteins |
Applicant | GENERAL ATOMICS 12889 GREGG COURT Poway, CA 92064 |
Contact | Abhijit Datta |
Correspondent | Abhijit Datta GENERAL ATOMICS 12889 GREGG COURT Poway, CA 92064 |
Product Code | MSJ |
Subsequent Product Code | JIT |
Subsequent Product Code | JJX |
CFR Regulation Number | 862.1475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-10-22 |
Decision Date | 2008-07-16 |
Summary: | summary |