The following data is part of a premarket notification filed by Statspin Technologies with the FDA for Statspin Mini-plasma.
| Device ID | K893613 |
| 510k Number | K893613 |
| Device Name: | STATSPIN MINI-PLASMA |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | STATSPIN TECHNOLOGIES 85 MORSE ST. Norwood, MA 02062 |
| Contact | Thomas Kelley |
| Correspondent | Thomas Kelley STATSPIN TECHNOLOGIES 85 MORSE ST. Norwood, MA 02062 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-10 |
| Decision Date | 1989-08-28 |