The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Il Test Pt-fibrinogen Recombinant.
| Device ID | K981479 |
| 510k Number | K981479 |
| Device Name: | IL TEST PT-FIBRINOGEN RECOMBINANT |
| Classification | Test, Time, Prothrombin |
| Applicant | INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington, MA 02173 |
| Contact | Carol Marble |
| Correspondent | Carol Marble INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington, MA 02173 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-24 |
| Decision Date | 1998-07-07 |
| Summary: | summary |