The following data is part of a premarket notification filed by Amoco Technology Co. with the FDA for Aks Ii.
Device ID | K895095 |
510k Number | K895095 |
Device Name: | AKS II |
Classification | Analyzer, Chromosome, Automated |
Applicant | AMOCO TECHNOLOGY CO. AMOCO RESEARCH CENTER P.O. BOX 400 Naperville, IL 60566 |
Contact | Marianne Urbauer |
Correspondent | Marianne Urbauer AMOCO TECHNOLOGY CO. AMOCO RESEARCH CENTER P.O. BOX 400 Naperville, IL 60566 |
Product Code | LNJ |
CFR Regulation Number | 864.5260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-08-14 |
Decision Date | 1990-02-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AKS II 74026548 1663763 Dead/Cancelled |
Amoco Technology Company 1990-02-07 |