The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Von Willebrand Activity Assay.
| Device ID | K133005 |
| 510k Number | K133005 |
| Device Name: | HEMOSIL VON WILLEBRAND ACTIVITY ASSAY |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Contact | Jacqueline Emery |
| Correspondent | Jacqueline Emery 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 | 2013-09-25 |
| Decision Date | 2014-03-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950078951 | K133005 | 000 |