The following data is part of a premarket notification filed by Statspin Technologies with the FDA for Statspin Statsampler.
| Device ID | K896206 |
| 510k Number | K896206 |
| Device Name: | STATSPIN STATSAMPLER |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | STATSPIN TECHNOLOGIES 85 MORSE ST. Norwood, MA 02062 |
| Contact | Thomas F Kelley,phd |
| Correspondent | Thomas F Kelley,phd 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 | 1989-10-26 |
| Decision Date | 1989-11-22 |