The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Acl Top 700 Las.
Device ID | K091980 |
510k Number | K091980 |
Device Name: | ACL TOP 700 LAS |
Classification | Instrument, Coagulation, Automated |
Applicant | INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
Contact | Carol Marble |
Correspondent | Carol Marble INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
Product Code | GKP |
CFR Regulation Number | 864.5400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-07-01 |
Decision Date | 2009-09-22 |
Summary: | summary |