The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Coamatic Plasmin Inhibitor.
| Device ID | K981817 |
| 510k Number | K981817 |
| Device Name: | COAMATIC PLASMIN INHIBITOR |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| 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 | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-22 |
| Decision Date | 1998-09-28 |
| Summary: | summary |