The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil D-dimer Hs.
Device ID | K151534 |
510k Number | K151534 |
Device Name: | HemosIL D-Dimer HS |
Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
Applicant | INSTRUMENTATION LABORATORY CO. 180 HARTWELL Road Bedford, MA 01730 |
Contact | Nikita Malladi |
Correspondent | Nikita Malladi INSTRUMENTATION LABORATORY CO. 180 HARTWELL Road Bedford, MA 01730 |
Product Code | DAP |
CFR Regulation Number | 864.7320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-06-08 |
Decision Date | 2015-07-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08426950358695 | K151534 | 000 |