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 |