The following data is part of a premarket notification filed by Diatech, Inc. with the FDA for Fibrinogentest-o.
| Device ID | K881685 |
| 510k Number | K881685 |
| Device Name: | FIBRINOGENTEST-O |
| Classification | Test, Fibrinogen |
| Applicant | DIATECH, INC. P.O. BOX 15700 Fort Lauderdale, FL 33318 |
| Contact | L Wilbourn |
| Correspondent | L Wilbourn DIATECH, INC. P.O. BOX 15700 Fort Lauderdale, FL 33318 |
| Product Code | GIS |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-19 |
| Decision Date | 1988-08-09 |