The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Fibrinogen-c.
| Device ID | K073367 |
| 510k Number | K073367 |
| Device Name: | HEMOSIL FIBRINOGEN-C |
| Classification | System, Fibrinogen Determination |
| 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 | KQJ |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-30 |
| Decision Date | 2007-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950478676 | K073367 | 000 |
| 08426950087618 | K073367 | 000 |