The following data is part of a premarket notification filed by Panbio, Inc. with the FDA for Abs Cadkit.
| Device ID | K910636 |
| 510k Number | K910636 |
| Device Name: | ABS CADKIT |
| Classification | Test, Fibrinogen |
| Applicant | PANBIO, INC. C/O BAKER & HOSTETLER 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
| Contact | Micha Barach |
| Correspondent | Micha Barach PANBIO, INC. C/O BAKER & HOSTETLER 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
| Product Code | GIS |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-13 |
| Decision Date | 1991-04-29 |