The following data is part of a premarket notification filed by Panbio, Inc. with the FDA for Tpp.
| Device ID | K962176 |
| 510k Number | K962176 |
| Device Name: | TPP |
| Classification | Prothrombin Fragment 1.2 |
| Applicant | PANBIO, INC. 1539 N. IRONWOOD DR. South Bend, IN 46635 |
| Contact | Christopher Notestine |
| Correspondent | Christopher Notestine PANBIO, INC. 1539 N. IRONWOOD DR. South Bend, IN 46635 |
| Product Code | MIF |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-05 |
| Decision Date | 1996-10-18 |
| Summary: | summary |