The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Factor Xii Deficient Plasma.
| Device ID | K180486 |
| 510k Number | K180486 |
| Device Name: | HemosIL Factor XII Deficient Plasma |
| Classification | Plasma, Coagulation Factor Deficient |
| 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 | GJT |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-23 |
| Decision Date | 2018-03-22 |
| Summary: | summary |