The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Recombiplastin 2g.
| Device ID | K070005 |
| 510k Number | K070005 |
| Device Name: | HEMOSIL RECOMBIPLASTIN 2G |
| 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 |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-03 |
| Decision Date | 2007-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950447627 | K070005 | 000 |