The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Il Test Fibrinogen-c.
| Device ID | K931721 |
| 510k Number | K931721 |
| Device Name: | IL TEST FIBRINOGEN-C |
| Classification | System, Fibrinogen Determination |
| Applicant | INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. P.O. BOX 9113 Lexington, MA 02173 |
| Contact | Wallis W Cady |
| Correspondent | Wallis W Cady INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. P.O. BOX 9113 Lexington, MA 02173 |
| Product Code | KQJ |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-07 |
| Decision Date | 1993-08-13 |