The following data is part of a premarket notification filed by Vital Scientific N.v. with the FDA for Vital Scientific Pt With Calcium.
| Device ID | K020840 |
| 510k Number | K020840 |
| Device Name: | VITAL SCIENTIFIC PT WITH CALCIUM |
| Classification | Test, Time, Prothrombin |
| 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 | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-15 |
| Decision Date | 2002-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10627944000032 | K020840 | 000 |
| 00627944000028 | K020840 | 000 |
| 00627944000011 | K020840 | 000 |
| 00850053916182 | K020840 | 000 |
| 00850053916205 | K020840 | 000 |