The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Silica Clotting Time.
Device ID | K160445 |
510k Number | K160445 |
Device Name: | HemosIL Silica Clotting Time |
Classification | Activated Partial Thromboplastin |
Applicant | INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 -2442 |
Contact | Heather L Harvey |
Correspondent | Heather L Harvey INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 -2442 |
Product Code | GFO |
CFR Regulation Number | 864.7925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-02-17 |
Decision Date | 2016-03-16 |
Summary: | summary |