The following data is part of a premarket notification filed by Vital Scientific N.v. with the FDA for Vitalab Flexor/vitalab Selectra 2/vitalab Viva.
| Device ID | K973628 |
| 510k Number | K973628 |
| Device Name: | VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA |
| Classification | Analyzer, Chemistry, Micro, For Clinical Use |
| Applicant | VITAL SCIENTIFIC N.V. ONE GATEWAY CENTER SUITE 415 Newton, MA 02158 |
| Contact | Israel M Stein |
| Correspondent | Israel M Stein VITAL SCIENTIFIC N.V. ONE GATEWAY CENTER SUITE 415 Newton, MA 02158 |
| Product Code | JJF |
| Subsequent Product Code | CDN |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGA |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JRE |
| Subsequent Product Code | JXO |
| Subsequent Product Code | KLT |
| Subsequent Product Code | LAR |
| CFR Regulation Number | 862.2170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-24 |
| Decision Date | 1998-03-13 |
| Summary: | summary |