The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Von Willebrand Factor Antigen.
| Device ID | K200033 |
| 510k Number | K200033 |
| Device Name: | HemosIL Von Willebrand Factor Antigen |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| 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 | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-07 |
| Decision Date | 2020-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950041177 | K200033 | 000 |