The following data is part of a premarket notification filed by Panbio, Inc. with the FDA for Fif Tm.
| Device ID | K970189 |
| 510k Number | K970189 |
| Device Name: | FIF TM |
| Classification | System, Fibrinogen Determination |
| Applicant | PANBIO, INC. 1539 N. IRONWOOD DR. South Bend, IN 46635 |
| Contact | Linda M Williams |
| Correspondent | Linda M Williams PANBIO, INC. 1539 N. IRONWOOD DR. South Bend, IN 46635 |
| Product Code | KQJ |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-21 |
| Decision Date | 1997-05-21 |
| Summary: | summary |