The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Recombiplastin 2g (8 Ml Vial).
| Device ID | K132722 |
| 510k Number | K132722 |
| Device Name: | HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL) |
| Classification | Test, Time, Prothrombin |
| 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 | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-30 |
| Decision Date | 2014-01-22 |