The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Pros.
| Device ID | K053499 |
| 510k Number | K053499 |
| Device Name: | HEMOSIL PROS |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | INSTRUMENTATION LABORATORY CO. 526 RT. 303 Orangeburg, NY 10962 |
| Contact | Carol Marble |
| Correspondent | Carol Marble INSTRUMENTATION LABORATORY CO. 526 RT. 303 Orangeburg, NY 10962 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-16 |
| Decision Date | 2006-01-13 |
| Summary: | summary |