The following data is part of a premarket notification filed by Vital Scientific N.v. with the FDA for Vital Scientific Aptt, Aptt & Quikcoag Aptt.
| Device ID | K022021 |
| 510k Number | K022021 |
| Device Name: | VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT |
| Classification | Activated Partial Thromboplastin |
| Applicant | VITAL SCIENTIFIC N.V. ONE GATEWAY CENTER SUITE 411 Newton, MA 02458 |
| Contact | Israel M Stein |
| Correspondent | Israel M Stein VITAL SCIENTIFIC N.V. ONE GATEWAY CENTER SUITE 411 Newton, MA 02458 |
| Product Code | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-20 |
| Decision Date | 2002-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10627944000100 | K022021 | 000 |
| 10627944000094 | K022021 | 000 |
| 00627944000059 | K022021 | 000 |
| 00627944000042 | K022021 | 000 |
| 00850053916199 | K022021 | 000 |