The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Recombi Plastin.
| Device ID | K012768 |
| 510k Number | K012768 |
| Device Name: | HEMOSIL RECOMBI PLASTIN |
| Classification | Test, Time, Prothrombin |
| 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 | GJS |
| Subsequent Product Code | GGP |
| Subsequent Product Code | GIS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-17 |
| Decision Date | 2001-09-18 |
| Summary: | summary |