The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Coamatic Factor Viii.
| Device ID | K981038 |
| 510k Number | K981038 |
| Device Name: | COAMATIC FACTOR VIII |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| 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 | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-19 |
| Decision Date | 1998-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950101697 | K981038 | 000 |
| 08426950088905 | K981038 | 000 |