The following data is part of a premarket notification filed by Pentapharm Ltd. with the FDA for Pefakit Apc-r Factor V Leiden Controls.
| Device ID | K042760 |
| 510k Number | K042760 |
| Device Name: | PEFAKIT APC-R FACTOR V LEIDEN CONTROLS |
| Classification | Plasma, Coagulation Control |
| Applicant | PENTAPHARM LTD. 1111 PENNSYLVANIA AVE., NW Washington, DC 20004 |
| Contact | M. Elisabeth Bierman |
| Correspondent | M. Elisabeth Bierman PENTAPHARM LTD. 1111 PENNSYLVANIA AVE., NW Washington, DC 20004 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-05 |
| Decision Date | 2004-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640175460020 | K042760 | 000 |